Existing law prohibits any person from collecting blood from animals, or preparing, testing, processing, storing, or distributing blood or blood component products, as defined, from animals, for retail sale and distribution except in a commercial blood bank for animals that is licensed by the Secretary of Food and Agriculture. Existing law requires a commercial blood bank for animals, as a condition of licensing, to document how the animal donor was acquired and to have a written protocol for, among other things, ongoing veterinary care for animals held in blood donor facilities. Existing law exempts all records held by the Department of Food and Agriculture pursuant to these provisions from disclosure pursuant to the California Public Records Act.

This bill would modify the definition of a commercial blood bank for animals to include establishments that collect blood not only from captive closed-colony animals that are kept, housed, or maintained for the purpose of collecting blood, but also community-sourced animals, as defined, that are brought by their owners to the commercial blood bank for animals to have their blood collected. The bill would define indirect supervision to have the same meaning as in specified regulations. The bill would require a commercial blood bank for animals to include in its written protocol, which would be required to be consistent with current standards of care and practice for the field of veterinary transfusion medicine, bloodborne pathogen testing for all canine and feline blood donors, as specified, and ongoing veterinary care, including an annual physical exam and vaccination schedule for animals held in a captive closed-colony. The bill would prohibit a commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animals blood or blood component products, and would impose specified requirements on a commercial blood bank for animals that accepts a donation from a community-sourced animal. The bill would require commercial blood banks for animals to annually submit a specified report to the department. The bill would require the department to submit a specified report to the Legislature on or before January 1, 2025. The bill would delete the above-described exemption from the California Public Records Act, except for identifying personal information, as defined, of owners of animal donors, as provided. The bill, for purposes of liability, would declare the production and use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into an animal to be construed to be, and would declare to be, the rendition of a service by each and every person, firm, or corporation participating, and would prohibit from being construed, and would be declared not to be, a sale of that whole blood, plasma, blood products, or blood derivatives.

Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

Under existing law, a violation of certain provisions of the Food and Agricultural Code relating to animals is a crime.

Because a violation of some of the above provisions would be a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

 VETO  

Bill No: SB 202

Author: Wilk (R), et al.

Amended: 8/12/19

Vote: 27

SENATE AGRICULTURE COMMITTEE: 4-0, 4/2/19

AYES: Galgiani, Wilk, Caballero, Glazer

SENATE JUDICIARY COMMITTEE: 9-0, 4/23/19

AYES: Jackson, Borgeas, Allen, Caballero, Jones, Monning, Stern, Umberg, Wieckowski

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SENATE FLOOR: 38-0, 5/21/19

AYES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

SENATE FLOOR: 40-0, 9/11/19

AYES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dahle, Dodd, Durazo, Galgiani, Glazer, Lena Gonzalez, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASSEMBLY FLOOR: 79-0, 9/10/19 - See last page for vote

SUBJECT: Animal blood donors

SOURCE: Author

DIGEST:

This bill (1) defines a commercial blood bank for animals to include “community-sourced” animals that are brought by their guardians to the commercial blood bank to have their blood collected; (2) requires the production of blood and blood products to be overseen by a licensed veterinarian; (3) removes the exemption for commercial blood banks from the California Public Records Act; (4) requires procedures and protocols to be consistent with current standards of care and practice for the field of veterinary transfusion medicine; (5) clarifies liability standards by construing the production of animal blood to be the rendition of a service rather than the sale of a product; (6) requires certain information to be reported to the California Department of Food and Agriculture (CDFA) and requires that information to be included in a report to the Legislature; and (7) changes “direct supervision” to “indirect supervision” to conform to existing definitions in the Food and Agricultural Code.

ANALYSIS:

Existing law:

1. Prohibits the offering for sale or use any animal blood and blood component product unless it is produced in an establishment licensed by the Secretary of the California Department of Food and Agriculture [Food and Agricultural Code 9241(b)]. California requires a license for each commercial blood bank for animals and requires the registration of each blood product being produced and sold. Application and licensing requirements must be met to qualify for licensure. Because of funding shortfalls in the state program, CDFA sponsored legislation in 2009-10 to eliminate the state biologics program and transition California to the federal biologics program.
2. Provides open access and accountability of government by giving the public access to records unless there is a legal reason not to do so [Government Code Section 6251, the California Public Records Act].
3. Exempts all records held by CDFA for a commercial blood bank from disclosure.

This bill:

1. Defines the following terms:
   1. “Captive closed-colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.
   2. “Community-sourced” means that an animal is both of the following:
      1. Kept, housed, and maintained at the residence of its owner.
      2. Brought in by its owner to a commercial blood bank for animals to have its blood collected.
   3. “Commercial blood bank for animals” means establishments that source collected blood from captive closed-colony animals or from community-sourced animals.
   4. “Identifying personal information” means the following information pertaining to the owner of a community-sourced animal donor that is maintained by the Department of Food and Agriculture in relation to this chapter: social security number, date of birth, physical description, home address, home telephone number, statements of personal worth or personal financial data, personal medical history, employment history, electronic mail address, and information that reveals any electronic network location or identity.
2. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to be consistent with current standards of care and practice for the field of veterinary transfusion medicine.
3. Requires the production of animal blood and blood component products to be under the indirect supervision of either a California-licensed veterinarian or a qualified person in the field for a commercial animal blood bank licensed before January 1, 2018.
4. Prohibits a licensed commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.
5. Requires blood-borne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
6. Exempts from the California Public Records Act any identifying personal information that is contained in records of the owner of a community-sourced animal donor, including, but not limited to, the person’s name, address, and telephone number.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Appropriations Committee, annual costs in the range of $200,000 to implement new animal blood bank standards, which includes staffing costs for one full-time Veterinarian Specialist and equipment and operating expenses. While CDFA can promulgate regulations to generate cost recovery, CDFA would need General Fund support in initial years of implementation. These costs are subject to some uncertainty because it is not yet known how many new licensees there will be as a result of this bill.

SUPPORT: (Verified 10/18/19)

Animal Blood Bank
Animal Legal Defense Fund
California News Publishers Association
California Veterinary Medical Association
Humane Society Veterinary Medical Association
People for the Ethical Treatment of Animals
Social Compassion in Legislation
Veterinary Medical Board, Department of Consumer Affairs

OPPOSITION: (Verified 10/18/19)

None received

ARGUMENTS IN SUPPORT: According to the author, “Current statute provides limited options for animal blood donors. SB 202 permits blood to be collected and sold from community-sourced animals, which will not only expand these options but also allow for more humane and ethical treatment of donors.

“Currently, all animal blood is sourced from “captive closed colonies.” Animals are kept in these blood banks just to give blood, and are often caged up 23 out of 24 hours of a day. SB 202 will simply open up the opportunity for community-sourced blood banks, allowing privately owned animals to donate blood and then go back into the community. The bill would also increase transparency requirements for commercial blood banks, and require blood-borne pathogen testing for all feline and canine donors.”

Social Compassion in Legislation states that community-sourced blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while allowing the donor animal to live a more humane life. They feel this bill will allow community-sourced blood banks to operate while leaving the current closed-colony blood banks mostly unaffected.

GOVERNOR'S VETO MESSAGE:

I am returning Senate Bill 202 without my signature.

This bill permits commercial blood banks for animals to collect blood from community-sourced animal blood and imposes rules around the collection of community-sourced animal blood.

I am supportive of changing California's law governing animal blood donation. However, this bill does not go far enough. I ask that the Legislature send me legislation that effectively leads to the phasing-out of "closed colonies," where dogs are kept in cages for months and years to harvest their blood for sale. The legislation should provide for the safe and humane treatment of donor animals, the welfare of the recipients and adequate oversight and enforcement of this program.

ASSEMBLY FLOOR: 79-0, 9/10/19

AYES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Daly, Diep, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Petrie-Norris, Quirk, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

Prepared by: Reichel Everhart / AGRI. /916-651-1508

10/24/19 10:21:28

**** END ****

 UNFINISHED BUSINESS  

Bill No: SB 202

Author: Wilk (R), et al.

Amended: 8/12/19

Vote: 21

SENATE AGRICULTURE COMMITTEE: 4-0, 4/2/19

AYES: Galgiani, Wilk, Caballero, Glazer

SENATE JUDICIARY COMMITTEE: 9-0, 4/23/19

AYES: Jackson, Borgeas, Allen, Caballero, Jones, Monning, Stern, Umberg, Wieckowski

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SENATE FLOOR: 38-0, 5/21/19

AYES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASSEMBLY FLOOR: 79-0, 9/10/19 - See last page for vote

SUBJECT: Animal blood donors

SOURCE: Author

DIGEST:

This bill (1) defines a commercial blood bank for animals to include “community-sourced” animals that are brought by their guardians to the commercial blood bank to have their blood collected; (2) requires the production of blood and blood products to be overseen by a licensed veterinarian; and (3) removes the exemption for commercial blood banks from the California Public Records Act.

Assembly Amendments

require procedures and protocols to be consistent with current standards of care and practice for the field of veterinary transfusion medicine; clarify liability standards by construing the production of animal blood to be the rendition of a service rather than the sale of a product; require reporting of certain information to the California Department of Food and Agriculture (CDFA) to be included in a report to the Legislature; and change “direct supervision” to “indirect supervision” to conform to existing definitions in the Food and Agricultural Code.

ANALYSIS:

Existing law:

1. Prohibits the offering for sale or use any animal blood and blood component product unless it is produced in an establishment licensed by the Secretary of the California Department of Food and Agriculture [Food and Agricultural Code 9241(b)]. California requires a license for each commercial blood bank for animals and requires the registration of each blood product being produced and sold. Application and licensing requirements must be met to qualify for licensure. Because of funding shortfalls in the state program, CDFA sponsored legislation in 2009-10 to eliminate the state biologics program and transition California to the federal biologics program.
2. Provides, pursuant to Government Code Section 6251, the California Public Records Act, open access and accountability of government by giving the public access to records unless there is a legal reason not to do so.
3. Exempts all records held by CDFA for a commercial blood bank from disclosure.

This bill:

1. Defines the following terms:
   1. “Captive closed-colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.
   2. “Community-sourced” means that an animal is both of the following:
      1. Kept, housed, and maintained at the residence of its owner.
      2. Brought in by its owner to a commercial blood bank for animals to have its blood collected.
   3. “Commercial blood bank for animals” means establishments that source collected blood from captive closed-colony animals or from community-sourced animals.
   4. “Identifying personal information” means the following information pertaining to the owner of a community-sourced animal donor that is maintained by the Department of Food and Agriculture in relation to this chapter: social security number, date of birth, physical description, home address, home telephone number, statements of personal worth or personal financial data, personal medical history, employment history, electronic mail address, and information that reveals any electronic network location or identity.
2. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to be consistent with current standards of care and practice for the field of veterinary transfusion medicine.
3. Requires the production of animal blood and blood component products to be under the indirect supervision of either a California-licensed veterinarian or a qualified person in the field for a commercial animal blood bank licensed before January 1, 2018.
4. Prohibits a licensed commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.
5. Requires blood-borne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
6. Exempts from the California Public Records Act any identifying personal information that is contained in records of the owner of a community-sourced animal donor, including, but not limited to, the person’s name, address, and telephone number.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Appropriations Committee, annual costs in the range of $200,000 to implement new animal blood bank standards, which includes staffing costs for one full-time Veterinarian Specialist and equipment and operating expenses. While CDFA can promulgate regulations to generate cost recovery, CDFA would need General Fund support in initial years of implementation. These costs are subject to some uncertainty because it is not yet known how many new licensees there will be as a result of this bill.

SUPPORT: (Verified 9/10/19)

Animal Blood Bank
Animal Legal Defense Fund
California News Publishers Association
California Veterinary Medical Association
Humane Society Veterinary Medical Association
People for the Ethical Treatment of Animals
Social Compassion in Legislation
Veterinary Medical Board, Department of Consumer Affairs

OPPOSITION: (Verified 9/10/19)

None received

ARGUMENTS IN SUPPORT: According to the author, “Current statute provides limited options for animal blood donors. SB 202 permits blood to be collected and sold from community-sourced animals, which will not only expand these options but also allow for more humane and ethical treatment of donors.

“Currently, all animal blood is sourced from “captive closed colonies.” Animals are kept in these blood banks just to give blood, and are often caged up 23 out of 24 hours of a day. SB 202 will simply open up the opportunity for community-sourced blood banks, allowing privately owned animals to donate blood and then go back into the community. The bill would also increase transparency requirements for commercial blood banks, and require blood-borne pathogen testing for all feline and canine donors.”

Social Compassion in Legislation states that community-sourced blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while allowing the donor animal to live a more humane life. They feel this bill will allow community-sourced blood banks to operate while leaving the current closed-colony blood banks mostly unaffected.

ASSEMBLY FLOOR: 79-0, 9/10/19

AYES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Daly, Diep, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Petrie-Norris, Quirk, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

Prepared by: Reichel Everhart / AGRI. / 916-651-1508

9/10/19 22:01:22

**** END ****

SENATE THIRD READING

STR Bill Id:SB 202

Author:(Wilk)

As Amended Ver:September 5, 2019

Majority vote

SUMMARY:

This bill permits commercial blood banks for animals (CBBA) to collect blood from community-sourced animal blood and imposes rules around the collection of community-sourced animal blood.

Major Provisions

1. Modifies the definition of CBBA to include establishments that produce animal blood or blood component products from community-sourced animals, which are animals kept, housed, maintained at their owners' residences or brought in by owners to a commercial blood bank to have its blood collected.
2. Prohibits a CBBA from paying for donated community-sourced animal blood and requires a commercial blood bank to ensure, through a licensed veterinarian providing indirect supervision, that the production of blood is safe and not injurious to the community source animal's health.
3. Requires a commercial blood bank to annually report to the California Department of Food and Agriculture (CDFA) on specified metrics related to community-sourced animal blood donations, and requires CDFA, by January 1, 2025, to submit a report to the Legislature on this information.
4. Delay the licensing and inspection portion of this bill, as it relates to CBBA, until January 1, 2021, or until CDFA has sufficient funds for licensing and inspection of CBBA.
5. Require CDFA to increase the CBBA license application fee to cover the increased cost of licensing and inspection of CBBAs included in this bill, and make public notice on CDFA's website a notice indicating that a CBBA fee structure is put in place.

COMMENTS:

Only two animal blood banks operate in California and hold licenses to produce, market and sell animal blood and blood products. These facilities provide whole blood, plasma, platelets and clotting factors to veterinary hospitals and clinics. The blood used to make these products is collected from an animal "blood donor" housed permanently or semi-permanently at the blood bank. California law does not allow pet owners to volunteer their animals as donors to commercial blood banks.

CDFA licenses and oversees commercial animal blood banks. CDFA inspects each facility at least once a year and sends two people on these inspections, one of whom is a veterinarian. California's two commercial animal blood banks have recently come under scrutiny for their practices, and in response to complaints, CDFA conducted a four-month investigation. The findings of this report are protected as confidential under current law, though the understanding is that allegations against these facilities were unfounded.

The most recent amendments delay the implementation of this bill to ensure CDFA has sufficient funds to issues licenses and perform inspections of new CBBAs.

According to the Author:

This bill will expand the animal blood supply, by allowing community sourced animal blood banks to operate in California; help save animal lives; and, allow pet owners to help their communities.

Arguments in Support:

An existing shortage of blood and blood products threatens the health and welfare of animals throughout California. While the two current closed-colony blood banks in California supply the majority of California animals and a significant supply to the nation, they cannot meet the demand– especially during natural disasters such as the recent wildfires. Furthermore, allowing open-colony blood banks to operate commercially in California would enable them to demonstrate their ability to provide safe canine blood and blood component products in sufficient supply to fulfill the needs of veterinary practitioner demands. Commercial operation of community-based canine blood banking in California will enhance animal well-being

Arguments in Opposition:

This bill does not go far enough in requiring operational standards and oversight of commercial blood banks for animals. They express deep concerns about the lack of provisions to phase out captive closed-colony blood banks, which the opponents views as inherently inhumane. Opponents argue: "Though the creation of community blood banks will help California, it is troublesome that SB 202 lacks several operational standards and oversight for this new industry, as well as the existing closed colony industry…[Additionally], we are deeply concerned that SB 202 makes no attempt to phase-out the cruel closed colonies."

FISCAL COMMENTS:

According to the Assembly Appropriations Committee, this bill has annual costs in the range of $200,000 to implement new animal blood bank standards, which includes staffing costs and equipment and operating expenses

VOTES:

SENATE FLOOR: 38-0-0

YES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASM JUDICIARY: 12-0-0

YES: Mark Stone, Gallagher, Chau, Chiu, Gonzalez, Holden, Kalra, Kiley, Maienschein, Obernolte, Petrie-Norris, Reyes

ASM AGRICULTURE: 11-0-0

YES: Eggman, Mathis, Aguiar-Curry, Cunningham, Flora, Gray, Irwin, Jones-Sawyer, Levine, Robert Rivas, Salas

ASM APPROPRIATIONS: 18-0-0

YES: Gonzalez, Bigelow, Bloom, Bonta, Brough, Calderon, Carrillo, Chau, Diep, Eggman, Fong, Gabriel, Eduardo Garcia, Maienschein, Obernolte, Petrie-Norris, Quirk, Robert Rivas

UPDATED:

VERSION: September 5, 2019

CONSULTANT: Victor Francovich / AGRI. / (916) 319-2084 FN: 0001903

SENATE THIRD READING

STR Bill Id:SB 202

Author:(Wilk)

As Amended Ver:August 12, 2019

Majority vote

SUMMARY:

This bill permits commercial animal blood banks to collect blood from community-sourced animal blood and imposes rules around the collection of community-sourced animal blood.

Major Provisions

1. Modifies the definition of "commercial blood bank for animals" to include establishments that produce animal blood or blood component products from community-sourced animals, which are animals kept, housed, maintained at their owners' residences or are brought by owners to a commercial blood bank to have its blood collected.
2. Prohibits a commercial blood bank from paying for donated community-sourced animal blood and requires a commercial blood bank to ensure, through a licensed veterinarian providing indirect supervision, that the production of blood is safe and not injurious to the community source animal's health.
3. Requires a commercial blood bank to annually report to the California Department of Food and Agriculture (CDFA) on specified metrics related to community-sourced animal blood donations, and requires CDFA, by January 1, 2025, to submit a report to the Legislature on this information.

COMMENTS:

Only two animal blood banks operate in California and hold licenses to produce, market and sell animal blood and blood products. These facilities provide whole blood, plasma, platelets and clotting factors to veterinary hospitals and clinics. The blood used to make these products is collected from an animal "blood donor" housed permanently or semi-permanently at the blood bank. California law does not allow pet owners to volunteer their animals as donors to commercial blood banks.

CDFA licenses and oversees commercial animal blood banks. As the Assembly Agriculture Committee notes, CDFA inspects each facility at least once a year and sends two people on these inspections, one of whom is a veterinarian. California's two commercial animal blood banks have recently come under scrutiny for their practices, and in response to complaints, CDFA conducted a four-month investigation. The findings of this report are protected as confidential under current law, though the understanding is that allegations against these facilities were unfounded.

According to the Author:

This bill will expand the animal blood supply, by allowing community sourced animal blood banks to operate in California; help save animal lives; and, allow pet owners to help their communities.

Arguments in Support:

An existing shortage of blood and blood products threatens the health and welfare of animals throughout California. While the two current closed-colony blood banks in California supply the majority of California animals and a significant supply to the nation, they cannot meet the demand– especially during natural disasters such as the recent wildfires. Furthermore, allowing open-colony blood banks to operate commercially in California would enable them to demonstrate their ability to provide safe canine blood and blood component products in sufficient supply to fulfill the needs of veterinary practitioner demands. Commercial operation of community-based canine blood banking in California will enhance animal well-being.

Arguments in Opposition:

This bill does not go far enough in requiring operational standards and oversight of commercial blood banks for animals. They express deep concerns about the lack of provisions to phase out captive closed-colony blood banks, which the opponents views as inherently inhumane. Opponents argue: "Though the creation of community blood banks will help California, it is troublesome that SB 202 lacks several operational standards and oversight for this new industry, as well as the existing closed colony" industry…[Additionally], we are deeply concerned that SB 202 makes no attempt to phase-out the cruel closed colonies. Californians would be horrified to know that dogs live in cages for years for the sole purpose of being bled."

FISCAL COMMENTS:

According to the Assembly Appropriations Committee, this bill has annual costs in the range of $200,000 to implement new animal blood bank standards, which includes staffing costs and equipment and operating expenses.

VOTES:

SENATE FLOOR: 38-0-0

YES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASM JUDICIARY: 12-0-0

YES: Mark Stone, Gallagher, Chau, Chiu, Gonzalez, Holden, Kalra, Kiley, Maienschein, Obernolte, Petrie-Norris, Reyes

ASM AGRICULTURE: 11-0-0

YES: Eggman, Mathis, Aguiar-Curry, Cunningham, Flora, Gray, Irwin, Jones-Sawyer, Levine, Robert Rivas, Salas

ASM APPROPRIATIONS: 18-0-0

YES: Gonzalez, Bigelow, Bloom, Bonta, Brough, Calderon, Carrillo, Chau, Diep, Eggman, Fong, Gabriel, Eduardo Garcia, Maienschein, Obernolte, Petrie-Norris, Quirk, Robert Rivas

UPDATED:

VERSION: August 12, 2019

CONSULTANT: Victor Francovich / AGRI. / (916) 319-2084 FN: 0001605

Date of Hearing: August 14, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 202

Author:(Wilk) – As Amended Ver:August 12, 2019

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill permits commercial animal blood banks to collect blood from community-sourced animal blood and imposes rules around the collection of community-sourced animal blood. Specifically, this bill:

1. Modifies the definition of “commercial blood bank for animals” to include establishments that produces animal blood or blood component products from community-sourced animals, which are animals kept, housed, maintained at their owners’ residences or are brought by owners to a commercial blood bank to have its blood collected.
2. Prohibits a commercial blood bank from paying for donated community-sourced animal blood and requires a commercial blood bank to ensure, through a licensed veterinarian providing indirect supervision, that the production of blood is safe and not injurious to the community source animal’s health.
3. Requires a commercial blood bank to annually report to the California Department of Food and Agriculture (CDFA) on specified metrics related to community-sourced animal blood donations, and requires CDFA, by January 1, 2025, to submit report to the Legislature on this information.

FISCAL EFFECT:

Annual costs in the range of $200,000 to implement new animal blood bank standards, which includes staffing costs for one full-time Veterinarian Specialist and equipment and operating expenses. While CDFA can promulgate regulations to generate cost recovery, CDFA would need General Fund support in initial years of implementation. These costs are subject to some uncertainty because it is not yet known how many new licensees there will be as a result of this bill (see comment #4.)

COMMENTS:

1. Animal blood banks. Only two animal blood banks operate in California and hold licenses to produce, market and sell animal blood and blood products. These facilities provide whole blood, plasma, platelets and clotting factors to veterinary hospitals and clinics. The blood used to make these products is collected from an animal "blood donor" housed permanently or semi-permanently at the blood bank. California law does not allow pet owners to volunteer their animals as donors to commercial blood banks.

CDFA licenses and oversees commercial animal blood banks. As the Assembly Agriculture Committee notes, CDFA inspects each facility at least once a year and sends two people on these inspections, one of whom is a veterinarian. California’s two commercial animal blood banks have recently come under scrutiny for their practices, and in response to complaints, CDFA conducted a four-month investigation. The findings of this report are protected as confidential under current law, though the understanding is that allegations against these facilities were unfounded.

1. Purpose. According to supporters, SB 202 will help expand access to community-based blood banks, which have proven to be safe, effective, and efficient. According to the Animal Legal Defense Fund, opening California up to community-based blood banks will “allow animals to live more humane lives with their human companions.”
2. Cost recovery. Under existing law, license fee for animal blood banks is $250, which is insufficient to cover the costs of implementing this bill. Existing law also allows CDFA to increase fees on animal blood banks to cover the reasonable costs of performing annual inspections. CDFA would likely utilize this authority to recover the costs of this bill, but until the fee increase is finalized there will be gap in fee revenues and ongoing enforcement costs associated with new animal blood bank licensees.
3. What will CDFA need to do? This bill’s costs are subject to some uncertainty because there is no concrete information on how many new licensees CDFA will need to oversee. However, this bill is likely to increase CDFA workload in two different ways:
4. A large increase in the number of animal blood banks relative to the status quo. As noted above, CDFA currently regulates just two licensed facilities, and given the interest in community-sourced animal blood donations, the number of licensees could very well double or triple.
5. Additional layers of oversight. In addition to more licensees, the nature of how these licensees receive donated blood will change. This bill imposes a range of standards around community-sourced blood donations, including the need for written consent from the animal owner and requirements around supervision of the blood donation so that blood products are safe and the animal is healthy.

Moreover, this bill imposes reporting requirements on licensees that will include technical medical information. Licensees must provide CDFA with an accounting on adverse events experienced by animals who donate blood. This bill does not require CDFA to do anything in particular with this information, but it does specify that any violation of this reporting requirement is cause for enforcement action by CDFA. Evaluating the accuracy of this information will require dedicated staff time, appropriate expertise and resources.

Analysis Prepared by: Luke Reidenbach / APPR. / (916) 319-2081

Date of Hearing: July 3, 2019

REVISED

ASSEMBLY COMMITTEE ON AGRICULTURE

Susan Talamantes Eggman, Chair

SBPCA Bill Id:SB 202

Author:(Wilk) – As Amended Ver:June 27, 2019

SENATE VOTE: 38-0

SUBJECT: Animal blood donors

SUMMARY: Permits licensed commercial animal blood banks in the state of California (State) to collect blood from animals that are kept, housed, and maintained at the residence of its owner (Community Blood Banks) and revises how commercial blood banks in California are operated. Specifically, this bill:

1. Redefines “commercial blood bank for animals” to include establishments that source collected blood from closed-colony animals or from community-sourced animals.
2. Defines “community-sourced” to mean that an animal is kept, housed, and maintained at the residence of its owner, and is brought by its owner to a commercial blood bank for the animal to have its blood collected.
3. Requires that commercial blood banks for animals produce animal blood and blood component products under the direct supervision of a licensed veterinarian.
4. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to be consistent with current standards of care and practice for the field of veterinary transfusion medicine.
5. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to include bloodborne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
6. Prohibits a licensed commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.
7. Defines “payment,” for the purposes of this provision, to mean the transfer by a licensed commercial blood bank for animals to a person of money or other valuable consideration that can be converted to money by the recipient, and expressly excludes from this definition fees for veterinary tests, screenings, or services that benefit the health of the community-sourced animal from which the blood or blood component products were taken.
8. Requires that a licensed commercial blood bank for animals that accepts a donation from a community-sourced animal do both of the following:
   1. Obtain the informed written consent of the owner of the community-sourced animal and keep a record of that consent; and,
   2. Ensure that the licensed veterinarian providing direct supervision determines that production of blood and blood component products is safe and not injurious to the community-sourced animal’s health, including ensuring that the community-sourced animal is an appropriate age to donate, a healthy weight to donate, has no history of bloodborne illness, and is current on vaccines.
9. Requires a licensed commercial blood bank for animals to maintain a record of the donations collected, units supplied, any adverse events, and any complaints from owners regarding community-sourced animals that donate blood or blood component products.
10. Provides that a violation of this section shall constitute a cause for discipline.
11. Applies the California Public Records Act (CPR ACT) to all records held by the Department of Food and Agriculture (CDFA) that relate to commercial blood banking for animals, except as specified, including, but not limited to, records relating to applications, fees, or inspections required under these provisions.
12. Exempts from disclosure under the CPR Act and deems confidential any identifying personal information of a community-sourced animal donor’s owner that is contained in records held by CDFA relating to these provisions.
13. Defines “identifying personal information,” for the purposes of these provisions, to mean the following information pertaining to the owner of a community-sourced animal donor that is maintained by CDFA in relation to this chapter: social security number, date of birth, physical description, home address, home telephone number, statements of personal worth or personal financial data, personal medical history, employment history, electronic mail address, and information that reveals any electronic network location or identity.
14. Specifies that nothing in these provisions shall prevent disclosure by CDFA of data regarding age, race, ethnicity, national origin, or gender of individuals whose personal information is protected pursuant to these provisions, so long as the data contain no individually identifiable information.
15. Provides that for purposes of liability, the production and use of animal blood and blood products pursuant to these provisions shall be considered the rendition of a service rather than the sale of product.
16. Defines “direct supervision” to have the same meaning as in the Veterinary Medicine Practice Act.
17. Requires a licensed commercial blood bank for animals to annually report information relating to the number of donations collected and units supplied from captive closed-colonies and community-sourced animals during that year, adverse events experienced by animals that donate blood from captive closed-colonies and community sources during that year, the number of repeat community-sourced donor animals, and the number of community-sourced and closed-colony donors whose blood tested positive for known pathogens during that year, to CDFA.
18. On or before January 1, 2025, requires CDFA to submit a report to the Legislature describing information collected pursuant to 17), the number of licensed commercial blood banks for animals in the state and the sources of animals from which they collect, and the number of violations of these provisions and of written protocols determined by inspection or complaint.

EXISTING LAW:

1. Prohibits any person from collecting blood from animals or preparing, testing, processing, storing, or distributing blood or blood component products, as defined, from animals, for retail sale and distribution except in a commercial blood bank for animals that is licensed by the Secretary of CDFA (Secretary), except as provided.
2. Defines “commercial blood bank for animals” to mean an establishment that produces animal blood or blood component products to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals.
3. Requires the Secretary to license establishments as commercial blood banks for animals that meet all of the following:
   1. operate under conditions, and use methods of production, to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful;
   2. produce animal blood and blood component products under the direct supervision of a person qualified in the field; and,
   3. maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of anesthesia on the animal, except as provided.
4. Requires an application for a license to contain specified information, including a written protocol that addresses all of the following:
   1. maximum length of time for donation by animal donors, or minimum health parameters for animal donors;
   2. frequency and volume of blood collected from animal blood donors;
   3. socialization and exercise programs for animal blood donors;
   4. method of identification of each animal, including microchip or tattoo;
   5. ongoing veterinary care, including an annual physical exam and vaccination schedule for animals held in blood donor facilities;
   6. husbandry standards for feeding, watering, sanitation, housing, handling, and care in transit, with minimums based on the standards set forth pursuant to the federal Animal Welfare Act; and,
   7. implementation of a permissive adoption program.
5. Governs the disclosure of information collected and maintained by public agencies pursuant to CPR Act.
   1. Provides that public records are open to inspection at all times during the office hours of the state or local agency and every person has a right to inspect any public record, except as provided.
   2. Generally, all public records are accessible to the public upon request, unless the record requested is exempt from public disclosure.
6. Provides that all records held by CDFA relating to commercial blood banks for animals including, but not limited to, records relating to applications, fees, or inspections, are confidential and are not subject to disclosure under CPR Act, except those records are accessible to law enforcement officers with jurisdiction, as provided.

FISCAL EFFECT: Unknown

COMMENTS: In California, two commercial blood banks for animals produce blood products under California licenses. Commercial blood banks for animals are establishments that produce animal blood products to market or sell for the use in the cure, mitigation, treatment or prevention of injury or disease in animals. California law prohibits the offering for sale or use of any animal blood product unless it is produced in an establishment licensed by CDFA. California requires a license for each commercial blood bank for animals establishment and requires the registration of each blood product being produced and sold. Application and licensing requirements must be met to qualify for licensure.

California requires all dog blood sold for veterinary purposes to come from a closed colony facility. A closed colony facility is a facility in which dogs live for a set amount of time solely for the purpose of donating blood. California veterinarians also may obtain blood for transfusions from other, healthy dogs being treated in their veterinary offices or from the dogs of their employees. Legislation last year clarified that licensed private veterinarians who collect blood products solely for use in their own practice is exempt from having to obtain an animal blood bank license.

Under current law, California veterinarians must purchase blood from a closed colony commercial blood bank in the state, or they can collect dog blood for use in their own practice. CDFA is responsible for all oversight of the closed colony commercial facilities in California, which is the only state with this type of regulated commercial blood banks. Other states handle canine blood for transfusions at local hospitals and clinics, which operate under federal regulations and veterinary medicine guidelines. Most out of state animal blood banks are Community Blood Donor Program (CBDP). The community blood bank system on other states allows for the sale of blood products.

The University of California at Davis (UCD) does operate a Canine CBDP. The UCD Veterinary Blood Bank began screening donor dogs in February 2008 for enrollment into a community-based donation program. The hospital’s blood bank collects, processes and stores canine blood needed for transfusions to treat a variety of conditions in dogs. UCD is not allowed to sell any canine blood products to other entities.

Critics of the closed colony model of blood banking consider it to be inhumane. Critics feel that keeping captive animals for the sole purpose of drawing their blood is ethically problematic. There have also been allegations that such blood banks do not provide sufficient space, exercise, or sanitation for their animals, though these claims have not been validated.

California and the rest of the nation consistently lack a sufficient supply of animal blood to meet the demand necessary for veterinary care. According to the author, this bill will allow community-based blood banks to operate and sell blood in California. This means a private dog owner would be able to volunteer their dog to safely donate blood under the supervision of a certified medical professional. While this model is practiced in much other state, it is not currently allowed in California. Opening up our laws to include this practice will ensure a consistent and bountiful supply of blood for the animals who need it so badly.

Currently, CDFA provides oversight of California Licensed Blood Banks for Animals. At a minimum of once per year, CDFA inspects every facility maintained by a Commercial Blood Bank for Animals that is licensed by the state. The expectations are laid out in statute, which also incorporate Federal Code of Regulations related to the Federal Animal Welfare Act. CDFA sends two people on these inspections, and one is always a veterinarian. Any issues are noted and re-checked for compliance.

CDFA investigates complaints and allegations, using an investigator if necessary. Recently, in response to a complaint against licensed blood bank, CDFA finished a four month long investigation into multiple allegations. The investigator spent 960 work hours gathering evidence, interviewing witnesses and compiling a report. While all of the allegations were unfounded or could not be sustained, the report is protected under current law.

This bill seeks to address the shortage of animal blood and blood products by permitting CDFA to license blood banks for animals that source the blood from the community. The bill creates several restrictions on the collection of animal blood from the community, including:

1. Prohibiting the provision of payment in exchange for animal blood donation.
2. Requiring that any blood bank collecting from community-sourced animals obtain the written consent of the owner of the animal and keep a record of that consent.
3. Ensuring a licensed veterinarian provides direct supervision to determine that it is safe and not injurious to collect from those animals.
4. Keeping records of all donations collected, units supplied, and adverse events or complaints regarding community-sourced donors.

Supporters state that the existing shortage of blood and blood products threatens the health and welfare of animals throughout California. While the two current closed-colony blood banks in California supply the majority of California animals and a significant supply to the nation, they cannot meet the demand– especially during natural disasters such as the recent wildfires. Furthermore, by allowing open-colony blood banks to operate commercially in California, would enable them to demonstrate their ability to provide safe canine blood and blood component products in sufficient supply to fulfill the needs of veterinary practitioner demands. Commercial operation of community-based canine blood banking in California will enhance animal well-being.

Opponents are concerned that the bill does not go far enough in requiring operational standards and oversight of commercial blood banks for animals. They express deep concerns about the lack of provisions to phase out captive closed-colony blood banks, which the opponents views as inherently inhumane. Opponents argues: “Though the creation of “community blood banks” will help California, it is troublesome that SB 202 lacks several operational standards and oversight for this new industry as well as the existing “closed colony” industry…[Additionally], we are deeply concerned that SB 202 makes no attempt to phase-out the cruel “closed colonies.” Californians would be horrified to know that dogs live in cages for years for the sole purpose of being bled. The creation of “community blood banks” provides an opportunity out of this old and inhumane practice, one that many states have already dissolved.” Opponents would like to see a phase-out of this inhumane practice added to SB 202.

Opponents state that recent amendments related to standards for operations, animal care, or client screening are still vague and should be more prescriptive. The current version bill requires that those operating a commercial animal blood bank follow guidelines “that are consistent with current standards of care and practice for the field of veterinary transfusion medicine.” Current state law states that animal blood banks in California comply with the Federal Animal Welfare Act. Furthermore, opponents would like to include sales data from commercial animal blood banks in the data submitted to CDFA and the report to the legislature.

The committee may wish to consider the following amendment to the definition of “direct supervision” and replace it with “indirect supervision.” The indirect supervision definition is closer in alignment to the current law and will help avoid a disruption in the animal blood supply.

Page 3, lines 22-25:

9502.7. Direct indirect supervision has the same meaning as in the regulations adopted pursuant to article 1 (commencing with section 4800) of Chapter 11 of Division 2 of the Business and Professions code.

The committee may wish to consider the following amendment to address the misplacement of language related to liability issue. Currently, in the bill, it is in the definition section and should be moved to its own section. This is a technical amendment.

Page 4, line 6:

(b) 9213 For the purposes of liability pursuant to this chapter, the production and use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into an animal shall be construed to be, and is declared to be, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives.

The bill currently only allows a commercial blood bank to operate under the direct supervision of a licensed veterinarian. This is a change from the current standard of qualified person in the field, which has been in place for more than 20 years. In that time there have been no major issues related to animal blood borne illnesses from California Commercial Animal Blood banks. The indirect supervision definition is closer in alignment to the current law and with avoid a disruption in the animal blood supply. Allowing current Commercial Animal Blood Banks to continue under the specific existing law will ensure continuity. The committee may wish to consider the following amendment to maintain and expand on the expertise of those can supervise the operation of a commercial animal blood bank.

Page 4, line 23-24:

Food and Ag Code 9212 (b) Produce animal blood and blood component products under the direct indirect supervision of a California licensed veterinarian or for a commercial animal blood bank licensed prior to January 1, 2018, a person qualified in the field.

The committee may wish to consider the following clarifying amendment to clarify that the report to the Legislature related to the Commercial Animal Blood Bank law is moved to its own section.

Page 7, lines 32-40 and page 8, lines 1-2:

9253 (B) 9254 (f) (1) On or before January 1, 2025, the department shall submit a report to the Legislature describing all of the following:

(A) Information collected pursuant to subdivision 9253 (e).

(B) The number of licensed commercial blood banks for animals in the state.

(C) The number of licensed commercial blood banks for animals collecting from community-sourced animals in the state, the number of licensed commercial blood banks for animals collecting from captive closed-colonies in the state, and the number of licensed commercial blood banks for animals collecting from both community-sourced animals and captive closed-colonies in the state.

(D) The number of violations of this section the provisions of this chapter, or of any rule or regulation adopted by the Secretary under this chapter, by routine inspection or investigation of a complaint

(E) The number of violations of submitted protocols determined by, routine inspection or investigation of a complaint.

The committee may wish to consider the following amendment to address, clarify, and specify the CDFA’s actions in response to violations of section 9253 of this bill.

Page 8, lines 15-16:

9253(d) A violation of this section shall constitute a cause for discipline corrective action, suspension, restriction, non-renewal or revocation of a license by the board Department. The proceedings for the suspension or revocation of a license or permit shall be conducted pursuant to Chapter 5 (commencing with Section 11500), Part 1, Division 3, Title 2 of the Government Code. The Secretary shall have all the powers granted in such chapter.

REGISTERED SUPPORT / OPPOSITION:

Support

Social Compassion in Legislation (Sponsor)

Animal Legal Defense Fund

California Veterinary Medical Association

California News Publishers Association

Department Of Consumer Affairs, Veterinary Medical Board

Humane Society Veterinary Medical Association

People for the Ethical Treatment of Animals (Peta)

Sean Owens, DVM (Medical Director, UC Davis Blood Bank)

People for the Ethical Treatment of Animals (Peta)

252 Individuals

Opposition

California Animal Welfare Association

Analysis Prepared by: Victor Francovich / AGRI. / (916) 319-2084

Date of Hearing: June 25, 2019

ASSEMBLY COMMITTEE ON JUDICIARY

Mark Stone, Chair

SBPCA Bill Id:SB 202

Author:(Wilk) – As Amended Ver:May 15, 2019

As Proposed to be Amended

SENATE VOTE: 38-0

SUBJECT: ANIMAL BLOOD DONORS

KEY ISSUE: SHOULD COMMERCIAL ANIMAL BLOOD BANKS IN THE STATE BE PERMITTED TO COLLECT BLOOD FROM COMMUNITY-SOURCED DONOR ANIMALS IN A MANNER SIMILAR TO HUMAN BLOOD DONATIONS?

SYNOPSIS

California and the rest of the nation consistently lack a sufficient supply of animal blood to meet the demand necessary for veterinary care. California, the only state that imposes significant restrictions on blood banking, licenses only one type of blood bank: captive closed-colony. These blood banks keep and maintain a colony of animals, typically dogs and cats, on site, and use these animals to produce blood and blood products. The benefit of this blood banking model is that closed-colonies are at lower risk of exposure to pathogens that could taint blood and harm other animals, and the colony is always available, providing a consistent blood supply. California is currently home to two such blood banks: the non-profit Hemopet and the for-profit Animal Blood Resources International, which supply most of California and much of the nation with animal blood and blood products. However, critics consider this model of blood banking to be inhumane; they argue that keeping captive animals for the sole purpose of drawing their blood is ethically problematic. There have also been allegations that such blood banks do not provide sufficient space, exercise, or sanitation for their animals, though these claims have been heavily disputed.

Critics argue that a more humane alternative exists in community-sourced blood banking for animals, a model similar to human blood banking in which donors (or in this case, their owners) volunteer to provide blood, typically in exchange for free veterinary care and priority for blood transfusion, if needed. Such banks have been successful elsewhere in operating safely and efficiently, but some concerns still remain about a wholesale switch to community-sourcing. The risk of pathogen exposure is significantly higher for community-sourced animals, especially since they may be exposed to pathogens in between draws. Additionally, because community-sourced blood banking is based on elective donation, there are concerns that the blood supply from a completely community-sourced industry would be inconsistent, resulting in a lack of supply when needed.

This bill seeks to address the shortage of animal blood and blood products by permitting the Secretary of California’s Department of Food and Agriculture to license blood banks for animals that source the blood from the community. The bill creates several restrictions on the collection of animal blood from the community, including prohibiting the provision of payment in exchange for animal blood donations, and requiring that any blood bank collecting from community-sourced animals obtain the written consent of the owner of the animal and keep a record of that consent, ensure a licensed veterinarian provides direct supervision to determine that it is safe to collect from those animals, and keep records of all donations collected, units supplied, and adverse events or complaints regarding community-sourced donors. The bill also relaxes restrictions on public disclosure of documents relating to commercial blood banking under the California Public Records Act. The author has accepted several clarifying amendments, as well as amendments to require that procedures and protocols are consistent with current standards of care and practice for the field of veterinary transfusion medicine, to clarify liability standards by construing the production of animal blood to be the rendition of a service rather than the sale of a product, and to require reporting of certain information to the department to be included in a report to the Legislature to inform future legislation. These proposed amendments are reflected in the analysis.

This bill is sponsored by Social Compassion in Legislation and is supported by various veterinary practice organizations and animal care advocacy groups, as well as the California News Publishers Association. These groups argue that this bill improves transparency, helps address blood shortages, and is a first step toward moving away from the inhumane practice of closed-colony blood banking. The current version of the bill is opposed, unless amended, by the California Animal Welfare Association, who are concerned that the bill doesn’t go far enough by not phasing out closed-colony blood banking nor imposing sufficient standards of care. Some of these concerns are addressed by the proposed amendments. The bill is double-referred to the Assembly Committee on Agriculture.

SUMMARY: Permits licensed commercial animal blood banks in the state to collect blood from animals that are kept, housed, and maintained at the residence of its owner. Specifically, as proposed to be amended, this bill:

1. Redefines “commercial blood bank for animals” to include establishments that source collected blood from captive closed-colony animals or from community-sourced animals.
2. Defines “community-sourced” to mean that an animal is kept, housed, and maintained at the residence of its owner, and is brought by its owner to a commercial blood bank for the animal to have its blood collected.
3. Requires that commercial blood banks for animals produce animal blood and blood component products under the direct supervision of a licensed veterinarian.
4. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to be consistent with current standards of care and practice for the field of veterinary transfusion medicine.
5. Requires the written protocol prepared pursuant to an application for a license to operate a commercial blood bank for animals to include bloodborne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
6. Prohibits a licensed commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.
7. Defines “payment,” for the purposes of this provision, to mean the transfer by a licensed commercial blood bank for animals to a person of money or other valuable consideration that can be converted to money by the recipient, and expressly excludes from this definition fees for veterinary tests, screenings, or services that benefit the health of the community-sourced animal from which the blood or blood component products were taken.
8. Requires that a licensed commercial blood bank for animals that accepts a donation from a community-sourced animal do both of the following:
   1. Obtain the informed written consent of the owner of the community-sourced animal and keep a record of that consent.
   2. Ensure that the licensed veterinarian providing direct supervision determines that production of blood and blood component products is safe and not injurious to the community-sourced animal’s health, including ensuring that the community-sourced animal is an appropriate age to donate, a healthy weight to donate, has no history of bloodborne illness, and is current on vaccines.
9. Requires a licensed commercial blood bank for animals to maintain a record of the donations collected, units supplied, any adverse events, and any complaints from owners regarding community-sourced animals that donate blood or blood component products.
10. Provides that a violation of this section shall constitute a cause for discipline by the board.
11. Applies the California Public Records Act to all records held by the Department of Food and Agriculture that relate to commercial blood banking for animals, except as specified, including, but not limited to, records relating to applications, fees, or inspections required under these provisions.
12. Exempts from disclosure under the California Public Records Act and deems confidential any identifying personal information that is contained in records held by the Department of Food and Agriculture relating to these provisions.
13. Defines “identifying personal information,” for the purposes of these provisions, to mean the following information pertaining to the owner of a community-sourced animal donor that is maintained by the Department of Food and Agriculture in relation to this chapter: social security number, date of birth, physical description, home address, home telephone number, statements of personal worth or personal financial data, personal medical history, employment history, electronic mail address, and information that reveals any electronic network location or identity.
14. Specifies that nothing in these provisions shall prevent disclosure by the department of data regarding age, race, ethnicity, national origin, or gender of individuals whose personal information is protected pursuant to these provisions, so long as the data contain no individually identifiable information.
15. Provides that for purposes of liability, the production and use of animal blood and blood products pursuant to these provisions shall be considered the rendition of a service rather than the sale of product.
16. Defines “direct supervision” to have the same meaning as in the Veterinary Medicine Practice Act.
17. Requires a licensed commercial blood bank for animals to annually report information relating to the number of donations collected and units supplied from captive closed-colonies and community-sourced animals during that year, adverse events experienced by animals that donate blood from captive closed-colonies and community sources during that year, the number of repeat community-sourced donor animals, and the number of community-sourced and closed-colony donors whose blood tested positive for known pathogens during that year, to the Department of Food and Agriculture.
18. On or before January 1, 2025, requires the Department of Food and Agriculture to submit a report to the Legislature describing information collected pursuant to 17), the number of licensed commercial blood banks for animals in the state and the sources of animals from which they collect, and the number of violations of these provisions and of written protocols determined by inspection or complaint.

EXISTING LAW:

1. Prohibits any person from offering for sale or use any blood or blood component product unless it is produced in an establishment licensed by the Secretary of the California Department of Food and Agriculture, except as provided. (Food & Agriculture Code Sections 9241 (b), 9272. All further references to code sections are in the Food & Agriculture Code unless otherwise provided.)
2. Defines “commercial blood bank for animals” to mean an establishment that produces animal blood or blood component products to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals. (Section 9205.)
3. Defines “production” to mean collection of blood or the preparation, testing, processing, storage, or distribution of blood or blood component products for the purpose of transfusion. (Section 9206.)
4. Provides that the secretary shall license establishments as commercial blood banks for animals that meet all of the following:
   1. Operate under conditions, and use methods of production, to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.
   2. Produce animal blood and blood component products under the direct supervision of a person qualified in the field.
   3. Maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of anesthesia on the animal. (Section 9212.)
5. Requires an application for a license for any establishment that produces, or proposes to produce, animal blood and blood component products shall contain all of the following:
   1. The name and address of the person who owns the place, establishment, or institution in which it is proposed to produce animal blood and blood component products.
   2. The name and address of the person who shall oversee the production of animal blood and blood component products.
   3. The type of animal blood and blood component products that shall be produced.
   4. A full description of the building, including its location, facilities, equipment, and apparatus to be used in the production of animal blood and blood component products.
   5. A written protocol including specified information.
   6. An “oversight letter” identifying the oversight veterinarian who will be responsible for oversight of the facility.
   7. Additional information the Secretary finds is necessary for proper administration and enforcement. (Section 9221(a)-(g).)
6. Requires a written protocol pursuant to 4) e) to address all of the following:
   1. Maximum length of time for donation by animal donors, or minimum health parameters for animal donors.
   2. Frequency and volume of blood collected from donors.
   3. Socialization and exercise programs for animal blood donors.
   4. Method of identification of each animal, including microchip or tattoo.
   5. Ongoing veterinary care, including an annual physical exam and vaccination schedule for animals held in blood donor facilities.
   6. Husbandry standards for feeding, watering, sanitation, housing, handling, and care in transit based on the federal Animal Welfare Act. (7 U.S.C. Section 2131 et seq.)
   7. Implementation of a permissive adoption program. (Section 9221 (e).)
7. Provides that, except as specified, all records held by the department relating to commercial blood banking for animals, including, but not limited to, records relating to applications, fees, or inspections required, shall be confidential and not subject to disclosure under the California Public Records Act. (Section 9269.)
8. Provides that the procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing into the human body shall be considered for all purposes to be the rendition of a service and shall not be considered to be a sale of such whole blood, plasma, blood products, or blood derivatives, for any purpose or purposes whatsoever. (Health & Safety Code Section 1606.)

FISCAL EFFECT: As currently in print this bill is keyed fiscal.

COMMENTS: California and the rest of the nation consistently lack a sufficient supply of animal blood to meet the demand necessary for veterinary care. California, the only state that imposes significant restrictions on blood banking, licenses only one type of blood bank: captive closed-colony. These blood banks keep and maintain a colony of animals, typically dogs and cats, on site, and use these animals to produce blood and blood products. The benefit of this blood banking model is that closed-colonies are at lower risk of exposure to pathogens that could taint blood and harm other animals, and that the colony is always available, providing a consistent blood supply. California is currently home to two such blood banks: the non-profit Hemopet and the for-profit Animal Blood Resources International, which supply most of California and much of the nation with animal blood and blood products. However, critics consider this model of blood banking to be inhumane, keeping captive animals for the sole purpose of drawing their blood can be considered ethically problematic. There have also been allegations that such blood banks do not provide sufficient space, exercise, or sanitation for their animals, though these claims have been heavily disputed.

Critics argue that a more humane alternative exists in community-sourced blood banking for animals, a model similar to human blood banking in which donors (or in this case, their owners) volunteer to provide blood, typically in exchange for free veterinary care and priority for blood transfusion if needed. Such banks have been successful elsewhere in operating safely and efficiently, but some concerns still remain about a wholesale switch to community-sourcing. The risk of pathogen exposure is significantly higher for community-sourced animals, especially since they may be exposed to pathogens in between draws. Additionally, because community-sourced blood banking is based on elective donation, there are concerns that the blood supply from a completely community-sourced industry would be inconsistent, resulting in a lack of supply when needed. It is difficult to assess which approach is ideal due to the pros and cons of each, as well as the opacity of records relating to animal blood banking practice. Such records are currently privileged with a blanket exemption from public disclosure under the California Public Records Act, so information held by the Department of Food and Agriculture relating to inspection and compliance of blood banks, as well as their protocols for practice and documentation of inventory, are not readily available.

This bill seeks to address the shortage of animal blood and blood products by permitting the Secretary of the Department of Food and Agriculture to license blood banks for animals that source the blood from the community. The bill creates several restrictions on the collection of animal blood from the community, including prohibiting the provision of payment in exchange for animal blood donations, and requiring that any blood bank collecting from community-sourced animals obtain the written consent of the owner of the animal and keep a record of that consent, ensure a licensed veterinarian provides direct supervision to determine that it is safe and not injurious to collect from those animals, and keep records of all donations collected, units supplied, and adverse events or complaints regarding community-sourced donors. The bill also relaxes restrictions on public disclosure of documents relating to commercial blood banking under the California Public Records Act.

The author has accepted several clarifying amendments, as well as amendments to require that procedures and protocols are consistent with current standards of care and practice for the field of veterinary transfusion medicine, to clarify liability standards by construing the production of animal blood and blood products to be the rendition of a service rather than the sale of a product, and to require reporting of certain information to the department to be included in a report to the Legislature to inform future legislation.

According to the author:

Veterinarians need a healthy supply of animal blood to perform transfusions and procedures in case of medical emergencies, but there is currently a nationwide shortage. As California has long been one of the nation’s top suppliers of these blood products, making a fix here is imperative. The state’s current regulatory framework only allows for the commercial licensure of closed-colony blood banks, which house animals on their property for potentially years on end. There are only two of these banks in California, and as they are beginning to run out of captive donors, the state (and, by extension, the nation) is beginning to run out of their badly needed blood products.

This bill will allow community-based blood banks to operate and sell blood in California. This means a private dog owner would be able to volunteer their dog to safely donate blood under the supervision of a certified medical professional. While this model is practiced in every other state, it is not currently allowed in California. Opening up our laws to include this practice will ensure a consistent and bountiful supply of blood for the animals who need it so badly.

The proper approach to addressing insufficient animal blood supply is disputed: captive closed-colony blood banking or community-sourced blood banking. California and the nation as a whole currently lack a sufficient supply of animal blood to meet demand. This means that many animals in dire need of blood transfusions do not have the requisite blood available, resulting in catastrophic fates. In order to maintain a consistent blood supply, it is necessary to have readily available sources for animal blood donations, yet veterinary experts disagree as to what approach to blood collection is safest and most ethical. Under current law, California licenses only one type of commercial blood banking: captive closed-colony blood banking. This model involves owning, keeping, housing, and maintaining a colony of animals on-site and drawing blood from these animals as needed, typically on a regular schedule. This approach has several benefits, including that the captive colony minimizes the risk of pathogen exposure and ensures that a source for blood will always be on hand when needed. California is home to two licensed commercial blood banks for animals: the for-profit Animal Blood Resources International, located in Northern California, and the Garden Grove-based nonprofit Hemopet, which supply the overwhelming majority of California veterinary hospitals (excluding those who collect from community-sourced animals for use on-site) as well as much of the nation as a whole. These blood banks contend that their donor animals are “happy, healthy, well-cared for and are adopted to good homes when their service is done.” (Teri Sfroza, Blood slave donor dogs may be rescued by regular dogs like yours if this California law passes, The Orange County Register, Feb. 7, 2019, https://www.ocregister.com/2019/02/07/your-dog-could-donate-blood-under-proposed-california-law-but-critics-say-more-pets-will-die/.)

However, many view the practice of captive closed-colony blood banking to be inherently inhumane. Critics of the model consider the animals used for their blood to be “blood slaves,” that are caged for the sole purpose of harvesting their blood or blood products. Due to a lack of public access to information relating to the practices of these blood banks, the conditions in which closed-colonies live are mysterious, and an “eyewitness investigation” by undercover operatives and whistleblowers published by PETA suggested that Hemopet subjected their colony of greyhounds to inhumane and unacceptable conditions, with insufficient space, exercise, and sanitation. (Expose Reveals Sick, Injured, Stressed Greyhounds Imprisoned and Bled Repeatedly at Hemopet, PETA, https://investigations.peta.org/hemopet-greyhounds-expose/.) Hemopet denies these claims.

Nonetheless, critics argue that a more humane alternative is available: community-sourced blood banking for animals. This model resembles the model used for human blood banking, relying on community volunteers to collect blood. The obvious benefit to the community-based model is that the conditions in which the animals are kept are likely significantly better, as they are pets to their respective owners and live in the homes of their owners. Additionally, community-sourced blood banking is significantly cheaper, as it avoids the necessary costs of maintaining the colony. On the other hand, critics of this model contend that it poses a higher risk of tainted blood supplies, since community-sourced animals are more likely to be exposed to pathogens and their exposure in between blood draws cannot be accounted for. Critics also express concerns that either volunteer participation wouldn’t be sufficient to meet the blood supply needs, or that it would be inconsistent, resulting in ebbs and flows of blood supply that can only be maintained for short periods, and leaving many animals in need without blood for procedures. California does not currently permit commercial blood banks for animals to use community-sourced blood, but many veterinary hospitals employ this model to collect blood for use at that hospital, which is permitted under California law. (Food and Agriculture Code Section 9272.) Community-sourced blood banking has, however, been highly successful in many other states in which it is permitted. For instance, a 2006 article published in the peer-reviewed Journal of Applied Animal Welfare Science documented the procedures of a pilot community-sourced blood bank for dogs in Florida with promising results. According to the article:

Nonprofit, volunteer, community donor programs can provide a safe and reliable blood supply without undue cost burden on the veterinary medical community. […] The primary justifications provided for captive donor programs do not appear to be valid, and the implementation and maintenance of such programs should be strongly discouraged in almost all instances. This is especially true of for-profit entities, in which ownership of donors by the blood bank creates an inherent conflict of interest. Community-based programs can provide an affordable, safe, and reliable blood supply while reducing the risk of exploiting animal donors. (DeLuca et al., Description and Evaluation of a Canine Volunteer Blood Donor Program (2006), Journal of Applied Animal Welfare Science, 9(2), p.140.)

This year, the Legislature is considering various ways to incorporate community-sourced blood banking for animals into the commercial landscape. AB 366 (Bloom) permits community-sourced blood banking in California, but would phase out the practice of closed-colony blood banking, making it ultimately unlawful. This bill takes a different approach, and permits community-sourced blood banking and closed-colony blood banking to coexist in California, aiming to better address the blood product needs of our nation’s animals. AB 366 is still in the Assembly Committee on Agriculture as a two-year bill.

The appropriate approaches to animal blood banking and the records thereof depend, in part, on ethical judgements defining the nature of the human-animal relationship. California law defines pets and other “domestic animals” as property of their owner. (Civil Code Section 655: “There may be ownership of…all domestic animals”; Penal Code Section 491: “Dogs are personal property and their value is to be ascertained in the same manner as the value of other property.”) Consideration of pets as property, especially with respect to valuation for damages, stems largely from common law and early American case law which assess the relationship between owners and domestic animals primarily as it relates to the economic value of livestock. Nonetheless, it is indisputable that Western society now considers the owner-pet relationship sacrosanct beyond typical property possession, and the United States Supreme Court has asserted that the onus for determining the extent to which pets are recognized as property rests on the nation’s legislatures. (Sentell v. New Orleans &c. Railroad Co. (1897) 166 U.S. 698, 701.) Several statutory provisions of California law, upheld by extensive case law, support special consideration for pets relative to other property, including providing for exemplary damages in cases of wrongful injuries to animals (Civil Code Section 3340) and criminalizing animal abuse and neglect (Penal Code Section 597 et seq.). (See also, e.g., Martinez v. Robledo (2012) 210 Cal.App.4th 384, 392; Kimes v. Grosser (2011) 195 Cal.App.4th 1556, 1563.)

Due to the obvious limitation that non-human animals cannot verbally consent to blood donation, the degree to which a community pet owner has the authority to consent on behalf of their pet depends on the degree of agency ascribed to that pet. Consent in any animal blood donation thus rests more on the whims and benefits to the owner, whether psychosocial or tangible, rather than the benefit to that specific animal. If we consider animals to be property, the ability of an owner to consent to a particular use, including risk of damage, is more or less unrestricted so long as that use is generally lawful. On the other hand, if we consider animals as more akin to dependents, as several state laws do, case law relating to the ability of a parent or guardian to consent on behalf of a child or a mentally incapacitated person seems more instructive. In this respect, case law has consistently demonstrated that a third-party guardian may consent to medical procedures (e.g., organ transplant or surgery) on behalf of a child or mentally incapacitated person so long as the consenting party is not, by judgment of the medical authority, acting against the best interests of the well-being of that person. (Curran v. Bosze (1990) 556 NE.2d. 1319); see also, e.g., Hart v. Brown (1972) 289 A.2d. 386; Strunk v. Strunk (1969) 445 SW.2d.) In these cases, courts have held that consideration of the psychological benefits of being informed of the altruistic act of providing an organ, for example, can be used as justification that the donation is in the best interest of the donor child. (See Curran v. Bosze, supra.)

In the case of a community-sourced animal, the donation provides psychological benefit to the owner, but the donor is likely incapable of understanding the benefits to other animals that arise from their donation. Consequently, under the aforementioned case law, it is unclear whether an owner should be permitted to consent on behalf of their pet to donate blood, which would at best provide no benefit to the animal, and at worst cause the animal temporary physical harm. While a veterinary expert recognizes the general benefit to all animals of such a donation, acting in the best interest of the particular patient should theoretically overrule the owner’s substituted consent.

Some community-sourced commercial blood banks for animals have addressed these ethical concerns in several ways. In addition to ensuring the animals are healthy enough to donate, some such banks will provide free health screenings, priority for blood transfusion if needed, and low-cost treats for the enjoyment of the animal. (See, e.g., DeLuca et al., Description and Evaluation, supra.) Without paying the owner, these considerations provide a benefit to the well-being of the animal that could justify the donation being considered to be in the animal’s best interest, thereby gelling appropriately with the consent considerations given to other living beings incapable of providing consent for medical procedures. Additionally, some banks have used cooperative or docile behavior to serve as a proxy for consent. For instance, one Florida bank would only collect blood from an animal following an assessment of voluntariness and cooperativeness prior to donation:

Donors were judged to be cooperative if they appeared to be at ease, would willingly stay in place on the table prior to donation, were cooperative with the holder, and did not require force to restrain during the donation process. (Id. at p.131.)

These techniques deserve notice, and it may behoove animal blood banks to incorporate these criteria as best practices in order to minimize concerns over animal consent for blood donation.

Commercial blood banks for animals are not required to operate in accordance with defined standards of care and practice for veterinary transfusion medicine. Current California law provides relatively sparse regulation of the commercial blood banking for animals. While animal blood banks are required to submit protocols and meet certain facilities requirements in order to receive licensure, the specific nature of acceptable protocols is poorly defined, and many practices within these establishments are largely self-governed. While there are standards that govern veterinary practice under the Veterinary Medicine Practice Act (Business and Professions Code Section 4800 et seq.) and for veterinary licensure, specifics relating to blood banking are not articulated in statute or regulation. Consequently, the frequency of blood draws appropriate, ages to which it is safe to draw blood, healthy weights, and the like are left largely to the interpretation of the bank itself. The result is that these banks, though presumably operating above board, are not held to a particular set of standards for veterinary transfusion. This bill provides some additional regulation of blood banking practices, mostly to create a regulatory framework for community-sourced banking. However, existing law and the bill in print do not specify that protocols submitted in applications for blood banking licenses must meet any particular standards of care or practice.

To ensure that practices in commercial blood banking are in line with leading guidelines on veterinary transfusion medicine, the author has accepted amendments to require that protocols are consistent with current standards of care and practice for veterinary transfusion medicine. There are multiple published collections of standards and guidelines for this practice (e.g. The American Association of Blood Banks standards) and the most cutting-edge and appropriate of these may change over time. With this in mind, the proposed amendment requires that current standards for the field are applied. The amendment reads as follows:

1. Operate under conditions, and use methods of production, that are consistent with current standards of care and practice for the field of veterinary transfusion medicine to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.

…

1. A written protocol consistent with current standards of care and practice for the field of veterinary transfusion medicine that addresses all of the following…

Additionally, while the bill in print requires that a licensed veterinarian provides direct supervision in order to determine the safety of drawing blood from a given community-sourced animal, it does not define “direct supervision.” In order to resolve any ambiguity as to the meaning of this phrase, the author has agreed to include an amendment defining direct supervision as the same as its use in the Veterinary Medicine Practice Act, as follows:

“Direct supervision” shall have the same meaning as in the regulations adopted pursuant to Article 1 of Chapter 11 of Division 2 (commencing with Section 4800) of the Business and Professions Code.

The collection, processing, and use of human blood is considered a service rather than a product to simplify assignment of liability, but this may not be true for animal blood. The proper assignment of liability in the event of harm resulting from commercially sourced human blood and blood products is relatively complex due to the lack of transparency as to blood “quality” for all persons in the chain of commerce. Under the American Law Institute’s Restatement (Third) of Torts: Products Liability, a product is defined as “tangible personal property distributed commercially for use or consumption.” The sale of blood could thus be considered the sale of a product, a consideration which imposes a standard of liability known as “strict liability,” meaning a party can be held liable for damages resulting from a defective product, even if the party was neither negligent or intentional in causing that harm.

The doctrine of strict products liability was first introduced in the Supreme Court of California in a concurring opinion by Justice Roger Traynor in Escola v. Coca Cola Bottling Co. (24 Cal.2d 453, 461-463 (1944)). Traynor suggested that a manufacturer of a product should be liable in tort for placing a defective product on the market that causes personal injury, as a consumer would be unable to prove that a defect was caused by a flaw in the manufacturing process, the manufacturer is best able to reduce the risks of injury caused by product defects, and a manufacturer can equitably distribute the loss among the buying public. (Ibid.) California became the first state to embrace this standard two decades later in Greenman v. Yuba Power Products, Inc. (59 Cal.2d. 57, 62-63 (1963).) The strict product liability standard was extended to apply to retailers as well the following year, as retailers “may be the only member of [the] enterprise reasonably available to the injured plaintiff” and “the retailer himself may play a substantial part in insuring that the product is safe or may be in a position to exert pressure on the manufacturer to that end.” (Jimenez v. Superior Court (2002) 29 Cal. 4th 473, at pp.477-478, quoting Vandermark v. Ford Motor Co. (1964) 61 Cal.2d 256, at pp.262-263.) Since then, several cases have held that, under California law, manufacturers, suppliers, and retailers could all be held strictly liable for harm caused by a defective product to a consumer, whether or not negligence or harmful intent was involved. (See e.g. Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 130; Barth v. B.F. Goodrich Tire Co. (1968) 265 Cal. App. 2d 228, 252-253; Kriegler v. Eichler Homes, Inc. (1969) 269 Cal. App. 2d 244; La Jolla Village Homeowners’ Assn. v. Superior Court (1989) 212 Cal. App. 3d 1131.)

Despite the technical application of this doctrine to human blood products based on the aforementioned definition of “product,” several courts and legislatures have recognized that considering human blood to be a product could be highly problematic, and may jeopardize the essential supply of human blood for those in need. The first court to recognize this issue was the New York Court of Appeals, which, in a case involving a patient who received a blood transfusion that was tainted with hepatitis and jaundice, ultimately held the blood transfusion to constitute a “service” rather than the sale of a product. (Perlmutter v. Beth David Hospital (1954) 300 N.Y. 100, 104.) The court reasoned:

If…the court were to stamp as a sale the supplying of blood – or the furnishing of other medical aid – it would mean that the hospital, no matter how careful, no matter that the disease-producing potential in the blood could not possibly be discovered, would be held responsible, virtually as an insurer, if anything were to happen to the patient as a result of the “bad” blood. (Id. at p.106.)

By considering the supplying of blood to be a service rather than a product sale, this designation avoids the application of strict liability, instead adopting a negligence standard typically applied to services, which holds a party liable only if the harm to the injured person resulted from a party’s negligence or intent to harm. In the wake of this decision, several state legislatures, including California’s, promptly enacted laws known as “blood shield statutes,” which expressly consider the production, distribution, and use of human blood and blood products to constitute the rendition of a service rather than the sale of a product, to avoid chilling blood donations and the production of blood products through liability for harm. (See, e.g., Murphy v. E.R. Squibb & Sons, Inc. (1985) 40 Cal. 3d 672, 680.) Today, 48 states have blood shield statutes to protect blood and blood products from strict products liability. California’s blood shield statute, found in Section 1606 of the Health & Safety Code, reads as follows:

The procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into the human body shall be construed to be, and is declared to be, for all purposes whatsoever, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives, for any purpose or purposes whatsoever. (Health & Safety Code Section 1606.)

California case law has held this statute to impose a liability for negligence standard, rather than a strict liability standard, to a hospital using blood in a transfusion (Shepard v. Alexian Brothers Hosp. (1973) 33 Cal. App. 3d 606), a blood bank supplying the blood (McDonald v. Sacramento Medical Foundation Blood Bank (1976) 62 Cal. App. 3d 866), and a manufacturer of blood plasma selling it for transfusion (Fogo v. Cutter Laboratories, Inc. (1977) 68 Cal. App. 3d 744). Section 19(c) of the Restatement (Third) of Torts has further clarified this beyond the previous Restatement to specify that “[h]uman blood and human tissue, even when provided commercially, are not subject to the Rules of this Restatement.”

It is unclear whether strict products liability applies to non-human animal blood and blood products under current California law, as the blood shield statute specifies human blood, and all applicable case law concerns human blood. Under the current regime of closed-colony blood banking, all blood and blood products are manufactured, collected, produced, and sold from the same establishment, and existing non-commercial blood banks that use community-sourced animals must collect and use the blood in-house. Thus, while one could envision a situation in which liability would need to be determined, this has not yet occurred, in part due to a relatively short chain of commerce.

By implementing community-sourced blood banking for commercial distribution, this bill would lengthen the chain of commerce underlying an animal blood product, as it would be collected by one party from an animal owned by another party, could potentially be processed in-house or sold elsewhere for processing, and then could be distributed by an additional party before transfusion. Should strict liability apply, any one of these parties could be held liable for defective blood, even in the absence of negligence. The same concerns that liability could jeopardize supply for the donation, collection, production, and distribution of animal blood products, especially when donation is performed on a volunteer basis, as are the case for human blood. Consequently, it is likely necessary to expressly provide immunity from strict liability for parties involved in the chain of commerce for animal blood products.

The author has prudently agreed to include such a statute, which is proposed to read as follows:

For the purposes of liability pursuant to this chapter, the production and use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into an animal shall be construed to be, and is declared to be, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives.

To avoid any interpretation that changes from the human blood shield statute in the language used for an animal blood shield statute are intended to distinguish its application from that of humans, the language proposed to be used was drawn directly from Section 1606 of the Health & Safety Code. The one modification made was to specify that the consideration of blood production and use as service is intended to apply only to questions of liability, leaving issues of taxation and the like for future resolution.

The bill in print removes the blanket exemption of records associated with commercial blood banking for animals from disclosure under the California Public Records Act. Under current law, all department records relating to licensed commercial blood banks for animals, including records relating to applications, fees, or inspections, are exempt from disclosure under the California Public Records Act. This blanket exemption is unusually broad and seems to withhold critical public access to information relating to the state’s fulfillment of its oversight obligations. As a result of this restriction, very little is known about the conditions under which captive closed-colony blood donors are kept, nor their general health and wellbeing. Furthermore, this lack of transparency has resulted in a dearth of available information relating to the commercial blood supply, which may be useful in informing the conduct of both closed-colony and community-sourced blood banking for animals to maximize public benefit.

The bill in print significantly limits the exemption applied to records relating to licensed commercial blood banks for animals, subjecting all such records in possession of the department to public disclosure under the Public Records Act, with minor exception. Identifying personal information of owners of community-sourced blood donor animals shall, under the bill in print, be considered confidential and shall not be subject to disclosure under the Public Records Act. Though such information would likely already be exempt under other exemptions in the Public Records Act, this specific exemption was included in order to minimize concern on the part of owners that the contributions of their animals could place them under potentially problematic public scrutiny. Expressly providing for confidentiality of identity therefore aids in maximizing the willingness of the public to voluntarily contribute to a community-sourced blood bank.

The intent of these provisions of the bill in print would not change substantively under the proposed amendments agreed to by the author. Rather, amendments to this section seek to clarify that existing exemptions under the Public Records Act, apart from those the bill directly affects, still apply to records relating to commercial blood banks for animals. Proposed amendments also remove the vagueness surrounding the phrase “including, but not limited to” in discussion of exempted identifying personal information, instead providing a comprehensive definition of “identifying personal information.” The proposed amendments are as follows:

9269. (a) Except as provided in subdivision (b), the California Public Records Act contained in Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code shall apply to all records held by the department relating to this chapter, including, but not limited to, records relating to applications, fees, or inspections required by this chapter, shall be subject to disclosure under the California Public Records Act contained in Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code.

(b) (1) Except as provided in subdivision (c), and notwithstanding subdivision (a), identifying personal information that is contained in records described in subdivision (a) due to a person’s status as the owner of a community-sourced animal donor, including, but not limited to, the person’s name, address, and phone number, shall be confidential and not subject to disclosure under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).

(2) “Identifying personal information,” for the purposes of this section, means the following information pertaining to the owner of a community-sourced animal donor that is maintained by the department in relation to this chapter: social security number, date of birth, physical description, home address, home telephone number, statements of personal worth or personal financial data, personal medical history, employment history, electronic mail address, and information that reveals any electronic network location or identity.

(3) Nothing in this section shall prevent disclosure by the department of data regarding age, race, ethnicity, national origin, or gender of individuals whose personal information is protected pursuant to this section, so long as the data contain no individually identifiable information.

The author has agreed to amend the bill to include essential reporting requirements for proper oversight and to inform future policy. The bill in print accomplishes several objectives simultaneously, all of which have been independently lauded by different supporting organizations. The bill is seen by some as a means of increasing the available animal blood supply to combat unmet demand, and by others as a first step toward phasing out what is viewed to be an inhumane practice of captive closed-colony blood banking. Still others view the bill as creating a window into the practices of the formerly opaque commercial animal blood banking industry, while others view it as a means of providing regulatory structure to ensure the wellbeing of animals participating in community donation.

One thing is certain: the bill opens the door to a new industrial practice in California, namely, the community-sourcing of animal blood and blood products for commercial distribution. It is thus essential that California appropriately assess and oversee the implementation of this new practice to better understand how it fits into the broader picture relating to animal blood availability, safety, and ethicality. Doing so can better inform future legislation relating to this industry, especially in light of the relative opacity of the industry in its current state. Furthermore, given the conflicting approaches to the implementation of community-sourced blood banking for animals that emerged in the Legislature this year (i.e. operating alongside closed-colonies vs. supplanting them), understanding the viability of community-sourced animal blood for sustaining the state and national blood supply is critical moving forward.

To ensure that the information necessary to evaluate the viability, safety, and ethicality of community-sourced blood banking, the author has agreed to amend the bill to include the mandatory reporting of certain information, primarily information that already must be maintained under the bill in print, from licensed commercial blood banks for animals to the Department of Food and Agriculture. This information includes the number of donations collected and units supplied from captive closed-colonies and from community-sourced animals, the number of animals experiencing adverse events, the total number of adverse events, and the nature of adverse events for animals for closed-colonies and for community-sourced animals, the number of community-sourced animal donors that donated more than once, and the number of community-sourced animals and of closed-colony animals whose blood tested positive for known pathogens. This information will help evaluate the safety of community sourcing and the extent to which community-sourcing may be capable of meeting blood demand either alone or in conjunction with closed-colony sourcing.

To facilitate the use of this information in informing future legislation, and to better publicize these data in order to better understand areas for improvement in the industry, the Department would, according to proposed amendments accepted by the author, be tasked with submitting a report to the Legislature including the information provided above, as well the number of licensed commercial blood banks for animals in the state, the sources from which they are collecting blood, and the number of violations of the requirements of these provisions and of their submitted protocols that have been determined by inspection or complaint. This report will ensure that the Legislature is properly equipped to oversee this changing industry, and to make more informed decisions in the future as to how closed-colony and community-sourced animal blood banking should be regulated. The proposed amendments are as follows:

(2) (A) A commercial blood bank for animals licensed under this chapter shall annually report the following information to the department:

1. The number of donations collected and units supplied from captive closed-colonies during that year.
2. The number of donations collected and units supplied from community-sourced animals during that year.
3. The number of animals experiencing adverse events, the number of total adverse events, and the nature of adverse events experienced by animals that donate blood or blood component products from captive closed-colonies during that year.
4. The number of animals experiencing adverse events and the number of total adverse events experienced by community-sourced animals that donate blood or blood component products, as well as the number and nature of complaints from owners regarding community-sourced animal donors, during that year.
5. The number of community-sourced animal donors that have donated blood or blood products more than once.
6. The number of community-sourced animal donors, and the number of closed-colony animal donors, whose blood tested positive for known pathogens, in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.

(B) On or before January 1, 2025, the department shall submit a report to the Legislature, in compliance with Section 9795 of the Government Code, describing all of the following:

1. Information collected pursuant to subparagraph (A) of paragraph (2) of subsection (c) of this section.
2. The number of licensed commercial blood banks for animals in the state.
3. The number of licensed commercial blood banks for animals collecting from community-sourced animals in the state, the number of licensed commercial blood banks for animals collecting from captive closed-colonies in the state, and the number of licensed commercial blood banks for animals collecting from both community-sourced animals and captive closed-colonies in the state.
4. The number of violations of this section determined by inspection or complaint.
5. The number of violations of submitted protocols determined by inspection or complaint.

ARGUMENTS IN SUPPORT: This bill is supported by animal care advocacy groups, the California News Publishers Association, the California Veterinary Medical Association, the Veterinary Medical Board of the Department of Consumer Affairs, and over 200 individuals. Supporters of the bill tout the benefits of community-sourced blood banking for addressing the shortage of animal blood in California and nationwide, helping to facilitate essential, life-saving veterinary procedures. Supporters also appreciate that this approach may reduce the reliance on closed-colony blood banking down the road, and applaud the clarification of liability as well as the additional transparency provided regarding the operations of commercial blood banks for animals.

The Animal Legal Defense Fund, an animal care advocacy organization, argues:

Animal blood banks help provide veterinarians with blood products needed for life-saving transfusions for dogs, cats, and many other animals. Current state law limits the supply of these lifesaving products by preventing blood collection from community-based banks. Community-based blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while also allowing for the donor animals to live a more humane life as the pet of a human companion compared to their counterparts living in captive closed-colony blood banks. SB 202 will simply allow for these community-based blood banks to operate, while leaving the current captive closed-colony blood bank model largely unaffected.

The California News Publishers Association, a trade organization and transparency advocacy group, adds:

Access to public records is essential for the public to hold government agencies accountable. For too long, the public has been unable to exercise its role in overseeing the California Department of Food and Agriculture as the regulator of animal blood banks as a result of the exemption found in Food and Agriculture Code Section 9269. Expansive exemptions to disclosure are antithetical to the right of access to public records found in both the CPRA and Article I, Section 2 of the California Constitution. CNPA supports the approach taken by SB 202 of creating a presumption of access to records with only limited exemptions for information in which the public’s interest is served by nondisclosure.

The Veterinary Medical Board of the Department of Consumer Affairs specifically mentions the benefits of this bill for securing a reliable blood supply for animal transfusions, arguing:

The existing shortage of blood and blood products threatens the health and welfare of animals throughout California. While the two current closed-colony blood banks in California supply the majority of California animals and a significant supply to the nation, the cannot meet the demand – especially during natural disasters such as the recent devastating wildfires. The board appreciates [the author’s] willingness to expand access to animal blood supply by allowing community-based models to operate in California while still retaining the existing closed-colony model.

ARGUMENTS IN OPPOSITION: The bill in print is opposed unless amended by the California Animal Welfare Association (CalAnimals), an animal care advocacy organization, who are concerned that the bill does not go far enough in requiring operational standards and oversight of commercial blood banks for animals. CalAnimals also expresses deep concerns about the lack of provisions to phase out captive closed-colony blood banks, which the organization views as inherently inhumane. CalAnimals argues:

Though the creation of “community blood banks” will help California, it is troublesome that SB 202 lacks several operational standards and oversight for this new industry as well as the existing “closed colony” industry…[Additionally], we are deeply concerned that SB 202 makes no attempt to phase-out the cruel “closed colonies.” Californians would be horrified to know that dogs live in cages for years for the sole purpose of being bled. The creation of “community blood banks” provides an opportunity out of this old and inhumane practice, one that many states have already dissolved. CalAnimals would like to see a phase-out of this inhumane practice added to SB 202. There are creative ways to tie the phase-out of captive colonies to the availability of animal blood and blood products from the newly formed “community blood banks.”

Although CalAnimals has not, as of the writing of this analysis, removed opposition from the bill, several of these concerns are addressed, at least in part, by the proposed amendments accepted by the author. The proposed amendments require that animal blood banking be performed in accordance with current standards of care and practice for veterinary transfusion medicine, clarify some technical confusion, and impose a reporting requirement to facilitate oversight. The inclusion of information about violations and adverse events can improve oversight, while collection of data relating to blood supply and quality from community-sourced animals can help inform future legislative action regarding, if appropriate and sustainable to meet the needs of California and the rest of the nation, the possible phase-out of closed-colony blood donation.

REGISTERED SUPPORT / OPPOSITION:

SUPPORT

Social Compassion in Legislation (sponsor)
Animal Legal Defense Fund
California News Publishers Association
California Veterinary Medical Association
Department of Consumer Affairs, Veterinary Medical Board
Humane Society Veterinary Medical Association
Sean Owens, DVM (Medical Director, UC Davis Blood Bank)
Numerous individuals

OPPOSE UNLESS AMENDED

California Animal Welfare Association

CONCERNS

Animal Blood Bank

Analysis Prepared by: Landon Klein / JUD. / (916) 319-2334

 THIRD READING  

Bill No: SB 202

Author: Wilk (R), et al.

Amended: 5/15/19

Vote: 21

SENATE AGRICULTURE COMMITTEE: 4-0, 4/2/19

AYES: Galgiani, Wilk, Caballero, Glazer

SENATE JUDICIARY COMMITTEE: 9-0, 4/23/19

AYES: Jackson, Borgeas, Allen, Caballero, Jones, Monning, Stern, Umberg, Wieckowski

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SUBJECT: Animal blood donors

SOURCE: Social Compassion in Legislation

DIGEST:

This bill (1) defines a commercial blood bank for animals to include “community-sourced” animals that are brought by their guardians to the commercial blood bank to have their blood collected; (2) requires the production of blood and blood products to be overseen by a licensed veterinarian; and (3) removes the exemption for commercial blood banks from the California Public Records Act.

Senate Floor Amendments of 5/15/19 make technical changes and add coauthors.

ANALYSIS:

Existing law:

1. Prohibits the offering for sale or use any animal blood and blood component product unless it is produced in an establishment licensed by the Secretary of the California Department of Food and Agriculture (CDFA) [Food and Agricultural Code 9241(b)]. California requires a license for each commercial blood bank for animals and requires the registration of each blood product being produced and sold. Application and licensing requirements must be met to qualify for licensure. Because of funding shortfalls in the state program, CDFA sponsored legislation in 2009-10 to eliminate the state biologics program and transition California to the federal biologics program.
2. Provides, pursuant to Government Code Section 6251, the California Public Records Act, open access and accountability of government by giving the public access to records unless there is a legal reason not to do so.
3. Exempts all records held by CDFA for a commercial blood bank from disclosure.

This bill:

1. Defines the following terms:
   1. “Captive closed-colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.
   2. “Community-sourced” means that an animal is both of the following:
      1. Kept, housed, and maintained at the residence of its guardian.
      2. Brought in by its guardian to a commercial blood bank for animals to have its blood collected.
2. Requires that the production of animal blood and blood component products is under the direct supervision of a licensed veterinarian.
3. Requires blood-borne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
4. Exempts from the California Public Records Act any identifying personal information that is contained in records of a guardian of a community-sourced animal donor, including, but not limited to, the person’s name, address, and telephone number.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 5/17/19)

Social Compassion in Legislation (source)

California News Publishers Association

California Veterinary Medical Association

California Veterinary Medical Board

OPPOSITION: (Verified 5/15/19)

None received

ARGUMENTS IN SUPPORT: According to the author, “Current statute provides limited options for animal blood donors. SB 202 permits blood to be collected and sold from community-sourced animals, which will not only expand these options but also allow for more humane and ethical treatment of donors.

“Currently, all animal blood is sourced from “captive closed colonies.” Animals are kept in these blood banks just to give blood, and are often caged up 23 out of 24 hours of a day. SB 202 will simply open up the opportunity for community-sourced blood banks, allowing privately owned animals to donate blood and then go back into the community. The bill would also increase transparency requirements for commercial blood banks, and require blood-borne pathogen testing for all feline and canine donors.”

Social Compassion in Legislation states that community-sourced blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while allowing the donor animal to live a more humane life. They feel this bill will allow community-sourced blood banks to operate while leaving the current closed-colony blood banks mostly unaffected.

Prepared by: Reichel Everhart / AGRI. / 916-651-1508

5/18/19 12:46:56

**** END ****

SENATE JUDICIARY COMMITTEE

Senator Hannah-Beth Jackson, Chair

2019-2020 Regular Session

Bill No: SB 202 (Author:Wilk)

Version: April 10, 2019

Hearing Date: April 23, 2019

Fiscal: Yes

Urgency: No

Consultant: AM

SUBJECT

Animal blood donors

DIGEST

This bill allows commercial blood banks for animals licensed by the Secretary of Food and Agriculture (Secretary) to produce animal blood or blood component products from community-sourced animals, requires the production of animal blood and blood component products to be done under the direct supervision of a licensed veterinarian, requires bloodborne pathogen testing for all canine and feline blood donors as specified. The bill provides that all records held by the California Department of Food and Agriculture (CDFA) regarding commercial blood banks for animals are subject to the California Public Records Act (CPRA) except for a person’s status as the owner of a community-sourced animal donor, which is confidential and not subject to disclosure under the CPRA, but provides that those records are accessible to law enforcement officers.

EXECUTIVE SUMMARY

There are two known commercial blood banks for animals in this state and they use the captive closed-colony model—meaning that they own, keep, house, and maintain animals, most often dogs and cats, for the sole purpose of taking their blood and selling the blood and blood component products. The bill would require these blood banks to produce blood under the direct supervision of a veterinarian and allow them to produce blood from community sourced animals, meaning an animal in the community who is voluntarily brought by its owner into the blood bank to donate blood. The bill would also repeal the complete exemption to the CPRA relating to commercial blood banks for animals licensed by the Secretary, except as specified.

The bill is sponsored by Social Compassion in Legislation (SCIL) and supported by the California Veterinary Medical Association and over 400 individuals. The bill is opposed by Animal Blood Bank. The bill passed the Senate Agriculture Committee on a vote of 4-0.

PROPOSED CHANGES TO THE LAW

Existing law:

1. Prohibits any person from collecting blood from animals or preparing, testing, processing, storing, or distributing blood or blood component products, as defined, from animals, for retail sale and distribution except in a commercial blood bank for animals that is licensed by the Secretary, except as provided. (Food & Ag. Code §§ 9210 & 9272.)
2. Defines “commercial blood bank for animals” to mean an establishment that produces animal blood or blood component products to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals. (Food & Ag. Code § 9205.)
3. Requires the Secretary to license establishments as commercial blood banks for animals that meet all of the following:
   1. operate under conditions, and use methods of production, to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful;
   2. produce animal blood and blood component products under the direct supervision of a person qualified in the field;
   3. maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of anesthesia on the animal, except as provided. (Food & Ag. Code §§ 9212(a)-(c) & 9268.)
4. Requires an application for a license to contain specified information, including a written protocol that addresses all of the following:
   1. maximum length of time for donation by animal donors, or minimum health parameters for animal donors;
   2. frequency and volume of blood collected from animal blood donors;
   3. socialization and exercise programs for animal blood donors;
   4. method of identification of each animal, including microchip or tattoo;
   5. ongoing veterinary care, including an annual physical exam and vaccination schedule for animals held in blood donor facilities;
   6. husbandry standards for feeding, watering, sanitation, housing, handling, and care in transit, with minimums based on the standards set forth pursuant to the federal Animal Welfare Act; and
   7. implementation of a permissive adoption program. (Food & Ag. Code § 9221.)
5. Governs the disclosure of information collected and maintained by public agencies pursuant to the CPRA. (Gov. Code §§ 6250 et seq.)
   1. Provides that public records are open to inspection at all times during the office hours of the state or local agency and every person has a right to inspect any public record, except as provided. (Gov. Code § 6253(a).)
   2. Generally, all public records are accessible to the public upon request, unless the record requested is exempt from public disclosure. (Gov. Code § 6253.)
6. Provides that all records held by CDFA relating to commercial blood banks for animals including, but not limited to, records relating to applications, fees, or inspections, are confidential and are not subject to disclosure under the CPRA, except those records are accessible to law enforcement officers with jurisdiction, as provided. (Food & Ag. Code § 9269.)

This bill:

1. Allows commercial blood banks for animals to produce animal blood or blood component products from community-sourced animals in addition to animals that are owned by the commercial blood bank.
   1. Revises the definition of “commercial blood bank for animals” to mean an establishment that produces animal blood or blood component products from captive closed-colony or community-sourced animals to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals.
   2. Defines “captive closed-colony” as an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.
   3. Defines “community-sourced” as an animal that is both:
      1. kept, housed, and maintained at the residence of its owner; and
      2. brought by its owner to a commercial blood bank for animals to have its blood collected.
   4. Makes various conforming changes.
2. Requires an establishment to produce blood and blood components products under the direct supervision of a licensed veterinarian.
3. Requires the written protocol to also address bloodborne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
4. Requires records held by CDFA regarding commercial blood banks for animals to be subject to the CPRA.
   1. Provides that identifying personal information that is contained in records due to a person’s status as the owner of a community-sourced animal donor, including, but not limited to, the person’s name, address, and phone number, is confidential and not subject to disclosure under the CPRA.
   2. Finds and declares that in order to protect the privacy of owners of community-sourced animal donors and encourage their participation in animal blood donation programs, it is necessary to limit the public’s right of access to their personal information

COMMENTS

1. Stated need for the bill

The author writes:

Current statute provides limited options for animal blood donors. SB 202 permits blood to be collected and sold from community-sourced animals, which will not only expand these options but also allow for more humane and ethical treatment of donors.

Currently, all animal blood is sourced from “captive closed colonies.” Animals are kept in these blood banks just to give blood, and are often caged up to 23 out of 24 hours of a day. SB 202 will simply open up the opportunity for community-sourced blood banks, allowing privately owned animals to donate blood and then go back into the community. The bill would also increase transparency requirements for commercial blood banks, and require blood-borne pathogen testing for all feline and canine donors.

The sponsor of the bill, SCIL, writes:

Animal blood banks help provide veterinarians with blood products needed for life-saving transfusions for dogs, cats, and many other animals. Current state law limits the supply of these lifesaving products by preventing blood collection from community-based banks. Community-based blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while also allowing for the donor animals to live a more humane life as the pet of a human companion compared to their counterparts living in captive closed-colony blood banks. SB 202 will simply allow for these community-based blood banks to operate, while leaving the current captive closed-colony blood bank model largely unaffected.

2. Captive colony model vs. community sourced model, ethics, and issues

In California there are two known commercial blood banks for animals licensed by the Secretary: the for profit Animal Blood Resources International, which has offices in Northern California and Michigan, and the nonprofit Hemopet in Garden Grove. These blood banks use the captive closed-colony model—meaning that they own, keep, house, and maintain animals, most often dogs and cats, for the sole purpose of taking their blood and selling the blood and blood component products. Hemopet, for example, “takes spent greyhounds from race tracks, uses them as canine blood donors for about a year, and then adopts them out as pets.”^[1] Animal Blood Resources International’s website seems to indicate it provides blood and blood products from dogs and felines.^[2]

Animal blood banks argue that without them there would be a shortage of available blood, that community-sourced blood may not be safe, and that their donor animals are “happy, healthy, well-cared for and are adopted to good homes when their service is done,” and are regulated by the CDFA.^[3] Patricia Kaufman of Animal Blood Resources International has said a community-sourced model “sounds great but will have deadly consequences, both in destroying an already-stretched blood supply and a regulatory structure proven to protect blood safety.”^[4]

Critics of the captive closed-colony model argue that these animals are essentially “blood slaves” and that a better and more ethical alternative would be to have community-sourced animal blood banks, similar to the existing model for humans.^[5] For example, the University of California, Davis currently runs a community blood bank that accepts blood donations from local dogs. Dr. Sean Owens, medical director of University of California, Davis’ veterinary blood bank, has been quoted as saying “controlled settings such as Hemopet allow for clean blood but modern veterinary science has progressed so that it can be obtained from ‘community’ banks.”^[6] A study published in the Journal of Applied Animal Welfare Science in 2006 concluded that:

Nonprofit, volunteer, community donor programs can provide a safe and reliable blood supply without undue cost burden on the veterinary medical community. […] The primary justifications provided for captive donor programs do not appear to be valid, and the implementation and maintenance of such programs should be strongly discouraged in almost all instances. This is especially true of for-profit entities, in which ownership of donors by the blood bank creates an inherent conflict of interest. Community-based programs can provide an affordable, safe, and reliable blood supply while reducing the risk of exploiting animal donors.^[7]

Another example is found in Pennsylvania where, according to an article in The Orange County Register:

About 25 years ago, the University of Pennsylvania’s Penn Animal Blood Bank had a well-run closed colony as well, officials said. But after sharp criticism from greyhound rescue groups, Penn closed the closed colony and switched to volunteer donations. Now Penn uses a doggie bloodmobile, where volunteer donor pets can give and go, much as humans do.^[8]

Recently, the People for the Ethical Treatment of Animals (PETA) published an “eyewitness investigation” of Hemopet where PETA claims their eyewitness reported that greyhounds were kept in inhumane and unacceptable conditions and sent complaints to local authorities.^[9] Hemopet has disputed these claims, calling them lies,^[10] and invited an Associated Press reporter to tour their facilities.^[11]

3. Blanket CPRA exemption under existing law

Under existing law there is a blanket exemption for all records relating to commercial blood banks for animals licensed by the Secretary, including records relating to applications, fees, or inspections. This blanket exemption seems unprecedented and antithetical to the California Constitution that provides:

The people have the right of access to information concerning the conduct of the people’s business, and, therefore, the meetings of public bodies and the writings of public officials and agencies shall be open to public scrutiny. (Cal. Const. Art. I, § 3(b)(1).)

As there is currently no way for the public to find out any information regarding commercial blood banks for animals, it is impossible for the public to assess whether PETA’s claims against Hemopet are valid, whether the existing regulatory model is working, or whether animals being held in these captive-closed colonies are “happy, healthy, well-cared for, and adopted to good homes” as the blood banks state. Making these records subject to the CPRA is an important first step to opening transparency around this industry that is currently shrouded in secret.

This bill is a first step in the right direction and arguably may not go far enough, considering the questionable ethics of keeping captive closed-colonies of dogs and cats for the sole purpose of providing blood to other dogs and cats that had the good fortune of being someone’s pet. Once these records are subject to the CPRA, the public and the Legislature will be able to better evaluate whether or not these blood banks are complying with existing law, are treating their captive animals humanely and appropriately, and whether or not the state should move towards a community-sourced model for animal blood banks.

4. Amendments

Due to the fact that there is no way to currently evaluate these blood banks and to ensure that community members who bring in their pets to these blood banks are doing so safely and for the right reasons, the Committee may wish to amend the bill to prohibit a blood bank from providing payment to a person who brings in a community-sourced animal, and that protections are enacted to ensure that the community-sourced animal is healthy enough to donate blood. The specific amendment is as follows:

Amendment

Section 9253 is added to the Food and Agricultural Code to read:

(a)(1) A commercial blood bank for animals licensed under this chapter shall not provide payment to a person who brings a community sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.

(2) For the purposes of this section, “payment” means the transfer by a commercial blood bank for animals licensed under this chapter to a person of money or other valuable consideration that can be converted to money by the recipient. For the purposes of this section, “payment” does not include fees for veterinary tests, screenings, or services that benefit the health of the community sourced animal from which the blood or blood component products was taken.

(b) A commercial blood bank for animals licensed under this chapter that accepts a donation from a community sourced animal shall do all of the following:

(1) Obtain the written consent of the owner of the community sourced animal and keep a record of that consent.

(2) Ensure that the licensed veterinarian providing direct supervision determines that production of blood and blood component products is safe and not injurious to the community sourced animal’s health, including ensuring that the community sourced animal is all of the following:

(A) An appropriate age to donate.

(B) A healthy weight to donate.

(C) Has no history of bloodborne illness.

(D) That the community sourced animal is current on vaccinations.

(c) A commercial blood bank for animals licensed under this chapter shall maintain a record of the donations collected, units supplied, any adverse events, and any complaints from owners regarding community sourced animals that donate blood or blood component products.

(d) A violation of this section shall constitute a cause for discipline by the board.

SUPPORT

Social Compassion in Legislation (sponsor)
California Veterinary Medical Association
Over 400 individuals

OPPOSITION

Animal Blood Bank®

RELATED LEGISLATION

Pending Legislation:

AB 366 (Bloom, 2019) prohibits, commencing January 1, 2022, a person from producing canine blood and blood component products or biologics for retail sale and distribution unless licensed as a canine blood bank by the Secretary, and would require a canine blood bank to collect blood only from a canine whose owner is a member of the public who voluntarily consents to the donation. AB 366 is currently pending in the Assembly Committee on Agriculture.

Prior Legislation:

AB 1709 (Ch. 235, Stats. 2010) recast and revised state law relating to the licensure of biologics to cover animal blood and blood components and products, and made biologic production subject to federal authority and permitting.

SB 1343 (Ch. 822, Stats. 2002) established additional protocols for commercial blood banks for animals licensed by the CDFA.

PRIOR VOTES:

Senate Agriculture Committee (Ayes 4, Noes 0)

**************

1. Sforza, Teri, Nonprofit greyhound rescue and dog bloodbank Hemopet is losing money, The Orange County Register (Jan, 6, 2019), available at https://www.ocregister.com/2017/01/06/nonprofit-greyhound-rescue-and-dog-blood-bank-hemopet-is-losing-money/ (as of Apr. 15, 2019). ↑

2. http://www.abrint.net/ (as of Apr. 15, 2019). ↑

3. Sforza, Teri, Blood slave’ donor dogs may be rescued by regular dogs like yours if this California law passes, The Orange County Register, (Feb. 7, 2019) available at https://www.ocregister.com/2019/02/07/your-dog-could-donate-blood-under-proposed-california-law-but-critics-say-more-pets-will-die/ (as of Apr. 15, 2019). ↑

4. Id. ↑

5. Id. ↑

6. Taxin, Amy, California canine blood bank disputes PETA abuse claims, Associated Press (Oct. 12, 2018) available at https://www.apnews.com/c80d207bd7574db492d090d5b5ebba11 (as of Apr. 15, 2019). ↑

7. DeLuca, Glass, Johnson, & Burger, Description and Evaluation of a Canine Volunteer Blood Donor Program, J. Applied Animal Wel. Science, 9(2), 129-141, at p. 140, available at http://www.avhtm.org/Resources/Documents/JAAWS2006.pdf (as of Apr. 15, 2019). ↑

8. Sforza, supra, fn. 3. ↑

9. PETA, Expose Reveals Sick, Injured, Stressed, Greyhounds Imprisoned and Bled Repeatedly at Hemopet, available at https://investigations.peta.org/hemopet-greyhounds-expose/ (as of Apr. 15, 2019). ↑

10. https://www.facebook.com/avmavets/posts/from-dr-doddsdear-friend-of-hemopeti-regretfully-announce-that-hemopet-the-non-p/10160452353583990/ (as of Apr. 18, 2019). ↑

11. Taxin, Amy, California canine blood bank disputes PETA abuse claims, Associated Press (Oct. 12, 2018) available at https://www.apnews.com/c80d207bd7574db492d090d5b5ebba11 (as of Apr. 15, 2019). ↑

SENATE COMMITTEE ON AGRICULTURE

Senator Cathleen Galgiani, Chair

2019 - 2020 Regular

Bill No: SB 202 Hearing Date: 4/2/19

Subject: Animal blood donors

SUMMARY

:

This bill would define a commercial blood bank for animals to include “community-sourced” animals that are brought by their guardians to the commercial blood bank to have their blood collected. The bill would also require commercial blood banks to include blood-borne pathogen testing for all canine and feline blood donors. The bill would require the production of blood and blood products to be overseen by a licensed veterinarian. The bill removes the exemption for commercial blood banks from the California Public Records Act. Personal information of guardians of community-sourced animal donors would still be protected under the California Public Records Act.

BACKGROUND AND EXISTING LAW

:

CDFA Veterinary Biologics Program was established in 1974 as a result of the 1971-72 exotic Newcastle disease outbreak that affected the poultry industry in Southern California. The program was modeled after the USDA’s Center for Veterinary Biologics Program. The program licensed biological products used in California and ensured that all available veterinary biologics were safe.

California law prohibits the offering for sale or use any animal blood and blood component product unless it is produced in an establishment licensed by the secretary [Food and Agricultural Code 9241(b)]. California requires a license for each commercial blood bank for animals and requires the registration of each blood product being produced and sold. Application and licensing requirements must be met to qualify for licensure. Because of funding shortfalls in the state program, CDFA sponsored legislation in 2009-10 to eliminate the state biologics program and transition California to the federal biologics program.

Currently, there are two licensed commercial blood banks in California: Hemopet in Garden Grove, California and Animal Blood Resources International in Dixon, California with a second location in Stockbridge, Michigan.

Government Code Section 6251, the California Public Records Act, was enacted in 1968 to provide Californians with open access and accountability of government by giving the public access to records unless there is a legal reason not to do so. Existing law exempts all records held by CDFA for a commercial blood bank from disclosure.

PROPOSED LAW

:

This bill:

1. Defines the following terms:
   1. “Captive closed-colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.
   2. “Community-sourced” means that an animal is both of the following:
      1. Kept, housed, and maintained at the residence of its guardian.
      2. Brought in by its guardian to a commercial blood bank for animals to have its blood collected.
2. Requires that the production of animal blood and blood component products is under the direct supervision of a licensed veterinarian.
3. Requires blood-borne pathogen testing for all canine and feline blood donors in accordance with the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
4. Exempts from the California Public Records Act any identifying personal information that is contained in records of a guardian of a community-sourced animal donor, including, but not limited to, the person’s name, address, and telephone number.

ARGUMENTS IN SUPPORT:

According to the author, “Current statute provides limited options for animal blood donors. SB 202 permits blood to be collected and sold from community-sourced animals, which will not only expand these options but also allow for more humane and ethical treatment of donors.”

“Currently, all animal blood is sourced from “captive closed colonies.” Animals are kept in these blood banks just to give blood, and are often caged up 23 out of 24 hours of a day. SB 202 will simply open up the opportunity for community-sourced blood banks, allowing privately owned animals to donate blood and then go back into the community. The bill would also increase transparency requirements for commercial blood banks, and require blood-borne pathogen testing for all feline and canine donors.”

Social Compassion in Legislation states that community-sourced blood banks have proven to be a safe, effective, and efficient way to collect donor blood, while allowing the donor animal to live a more humane life. They feel this bill will allow community-sourced blood banks to operate while leaving the current closed-colony blood banks mostly unaffected.

ARGUMENTS IN OPPOSITION:

None received.

COMMENTS

:

This bill would allow community-sourced animals to be used to collect blood so long as they are brought to the blood bank for collection by their “guardian”. In several places, the bill references the “guardian” of the animal. The California Veterinary Medical Association has noted that the use of the word “guardian” has legal implications that would prevent them from being supportive of the legislation. The committee may wish to consider an amendment that would strike the word “guardian” and replace it with “owner.”

This bill requires the production of blood and blood products to be overseen by a licensed veterinarian. Food and Agriculture Code, Section 9221 states that licensed establishments must produce animal blood and blood component products under the direct supervision of a person qualified in the field, must have an “oversight letter” on file with CDFA that identifies the veterinarian who will be responsible for oversight of the facility. The section also states that the secretary may ask for additional information, as needed.

The Senate Rules Committee has double referred this bill to the Senate Judiciary Committee as the second committee of referral.  Therefore, if this measure is approved by this committee, the motion should include an action to re-refer the bill to the Senate Committee on Judiciary.

RELATED LEGISLATION

:

AB 1709 (Chapter 235, Statutes of 2010): Deleted the state biologics licensure law and recast it to cover animal blood and blood components and products. It also made biologic production subject to federal authority and permitting.

SB 1343 (Chapter 822, Statutes of 2002): Established additional protocols for commercial blood banks for animals that are licensed by the CDFA.

SUPPORT

:

Social Compassion in Legislation (Sponsor)

164 individuals

OPPOSITION

:

None received

-- END --